Anesthesiology
Review Panel
- CardiovascularReview Panel
- ChemistryReview Panel
- DentalReview Panel
- Ear, Nose, ThroatReview Panel
- Gastroenterology and UrologyReview Panel
- General HospitalReview Panel
- HematologyReview Panel
- ImmunologyReview Panel
- MicrobiologyReview Panel
- MiscellaneousMiscellaneous
- PBKNon-Variola Orthopoxvirus Real-Time Pcr Primer And Probe Set2Product Code
- OBFAssay, Genotyping, Hepatitis C Virus3Product Code
- QHMSerology Tests Used For Infectious Disease Screening Of Blood And Plasma DonationsUProduct Code
- PRAVariola Virus Nucleic Acid-Based Detection Assay2Product Code
- PVQRickettsia Spp. Nucleic Acid Based Detection Assay2Product Code
- QHONucleic-Acid Tests Used For Infectious Disease Screening Of Blood And Plasma DonationsUProduct Code
- QIDDevice To Detect Antigens Of Biothreat Microbial Agents In Human Clinical Specimens2Product Code
- MZPAssay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus3Product Code
- K252484cobas HCV3Cleared 510(K)
- K252102Alinity m HCV3Cleared 510(K)
- K233352Aptima HCV Quant Dx Assay3Cleared 510(K)
- K221007cobas HCV3Cleared 510(K)
- P190025Alinity m HCVAPPRPMA Approval
- P160023APTIMA HCV QUANT DX ASSAYAPPRPMA Approval
- P150015COBAS HCV TESTAPPRPMA Approval
- P100017ABBOTT REALTIME HCV, ABBOTT REALTIME HCV AMPLIFICATION REAGENT KIT, ABBOTT REALTIME HVC CONTROL KIT, ABBOTT REALTIME HCVAPPRPMA Approval
- P060030COBAS AMPLIPREP/COBAS TAQMAN HCV TESTAPPRPMA Approval
- P020022BAYER VERSANT (TM) HCV RNA 3.0 ASSAY (BDNA)APWDPMA Approval
- P100017Abbott RealTime HCV3PMA Approval
- P190025Alinity m HCV3PMA Approval
- P150015cobas HCV3PMA Approval
- P100017Abbott RealTime HCV Assay3PMA Approval
- P150015cobas HCV3PMA Approval
- P150015cobas HCV3PMA Approval
- P060030COBAS AmpliPrep/COBAS TaqMan HCV Test, v2.03PMA Approval
- P150015cobas HCV3PMA Approval
- P160023Aptima HCV Quant Dx Assay3PMA Approval
- P020011Aptima HCV RNA Qualitative Assay3PMA Approval
- P190025Alinity m HCV3PMA Approval
- P150015cobas HCV3PMA Approval
- P060030COBAS® TaqMan® HCV Test, v2.0, for Use with the High Pure System and COBAS® AmpliPrep/ COBAS® TaqMan® HCV Test, v2.03PMA Approval
- P190025Alinity m HCV3PMA Approval
- P190025Alinity m HCV3PMA Approval
- P060030Cobas AmpliPrep/Cobas Taqman HCV Test v2.03PMA Approval
- P160023Aptima HCV Quant Dx Assay3PMA Approval
- P020011Aptima HCV RNA Qualitative Assay3PMA Approval
- P150015cobas HCV3PMA Approval
- P160023Aptima HCV Quant Dx Assay3PMA Approval
- P150015COBAS HCV TEST3PMA Approval
- P160023Aptima HCV Quant Dx Assay3PMA Approval
- P150015Cobas HCV3PMA Approval
- P060030COBAS AmpliPrep/COBAS TaqMan HCV Test v2.03PMA Approval
- P060030Cobas TaqMan HCV Test, v2.0, for Use with the High Pure System and Cobas AmpliPrep, Cobas TaqMan HCV Test, v2.03PMA Approval
- P150015cobas HCV Test3PMA Approval
- P150015cobas HCV3PMA Approval
- P060030COBAS AmpliPrep/COBAS TaqMan HCV Test V2.03PMA Approval
- P150015cobas HCV3PMA Approval
- P060030cobas AmpliPrep/cobas TaqMan HCV Test, v23PMA Approval
- P160023Aptima HCV Quant Dx Assay3PMA Approval
- P020011Aptima HCV RNA Qualitative Assay3PMA Approval
- P060030COBAS AmpliPrep/COBAS TaqMan HCV Test v2.03PMA Approval
- P150015Cobas HCV3PMA Approval
- P150015Cobas HCV3PMA Approval
- P150015Cobas HCV Test3PMA Approval
- P060030COBAS TaqMan HCV Test, v2.0, for use with the High Pure System and COBAS AMpliPrep/COBAS TaqMan HCV Test, v2.03PMA Approval
- P150015cobas HCV3PMA Approval
- P160023Aptima HCV Quant Dx Assay3PMA Approval
- P100017RealTime HCV3PMA Approval
- P060030Cobas AmpliPrep/Cobas TaqMan HCV Test, v2.03PMA Approval
- P150015Cobas HCV Test3PMA Approval
- P150015COBAS HCV TEST3PMA Approval
- P060030COBAS TaqMan HCV Test, v2.0 for use on the High Pure System3PMA Approval
- P150015cobas HCV3PMA Approval
- P160023APTIMA HCV Quant Dx Assay3PMA Approval
- P020011APTIMA HCV RNA Qualitative Assay3PMA Approval
- P160023APTIMA HCV Quant Dx Assay3PMA Approval
- P150015cobas HCV Test3PMA Approval
- P060030COBAS AmpliPrep/COBAS TaqMan HCV Test, v2.03PMA Approval
- P160023Aptima HCV Quant Dx Assay3PMA Approval
- P020011Aptima HCV RNA Qualitative Assay3PMA Approval
- P160023Aptima HCV Quant Dx Assay3PMA Approval
- P060030COBAS AmpliPrep/COBAS TaqMan HCV Test3PMA Approval
- P150015cobas HCV3PMA Approval
- P160023Aptima HCV Quant Dx Assay3PMA Approval
- P060030COBAS AmpliPrep/COBAS TaqMan HCV Test, v2.0 and COBAS TaqMan HCV Test, v2.0 for use on the High Pure System3PMA Approval
- P150015cobas HCV3PMA Approval
- P060030COBAS AmpliPrep/COBAS TaqMan HCV Test, v2.0 and COBAS TaqMan HCV TEst, v2.0 for use on the High Pure System3PMA Approval
- P150015cobas HCV3PMA Approval
- P160023Aptima HCV Quant DX Assay3PMA Approval
- P020011Aptima HCV RNA Qualitative Assay3PMA Approval
- P160023Aptima HCV Quant Dx Assay3PMA Approval
- P160023Aptima HCV Quant Dx Assay3PMA Approval
- P060030COBAS AmpliPrep/COBAS TaqMan HCV Test, v2.0 and COBAS TaqMan HCV Test, v2.0 for use on the High Pure System3PMA Approval
- P150015cobas HCV3PMA Approval
- P060030COBAS AmpliPrep/COBAS TaqMan HCV Test, v2.0 and COBAS TaqMan HCV Test, v2.0 for use on the High Pure System3PMA Approval
- P150015cobas HCV3PMA Approval
- P160023Aptima HCV Quant Dx Assay3PMA Approval
- P150015Cobas HCV3PMA Approval
- P060030COBAS AmpliPrep/COBAS TaqMan HCV Test, v2.03PMA Approval
- P150015cobas HCV3PMA Approval
- P060030COBAS AmpliPrep/COBAS TaqMan HCV Test, v2.03PMA Approval
- P060030COBAS TaqMan HCV Test, v2.0, For use with the High Pure System, High Pure System Viral Nucleic Acid Kit3PMA Approval
- P150015cobas HCV Test3PMA Approval
- P100017Abbott RealTime HCV Assay3PMA Approval
- P160023Aptima HCV Quant Dx Assay3PMA Approval
- P060030Cobas AmpliPrep/Cobas TaqMan HCV Test, v2.03PMA Approval
- P150015Cobas HCV3PMA Approval
- P060030Cobas AmpliPrep/Cobas TaqMan HCV Test, v2.03PMA Approval
- P160023Aptima HCV Quant Dx Assay3PMA Approval
- P060030Cobas AmpliPrep/Cobas TaqMan HCV Test, v.203PMA Approval
- P150015Cobas HCV Test3PMA Approval
- P160023Aptima HCV Quant Dx Assay3PMA Approval
- P150015Cobas HCV Test3PMA Approval
- P060030Cobas TaqMan HCV Test, v2.03PMA Approval
- P150015Cobas HCV3PMA Approval
- P150015Cobas HCV3PMA Approval
- P020011Aptima HCV RNA Qualitative Assay3PMA Approval
- P150015cobas HCV Test3PMA Approval
- P060030COBAS AmpliPrep/COBAS TaqMan HCV Test, v2.03PMA Approval
- P150015Cobas HCV Test3PMA Approval
- P060030COBAS AmpliPrep/COBAS TaqMan HCV Test, v 2.03PMA Approval
- P100017Abbott Real Time HCV Amplification Reagent Kit /HCV Control Kit /HCV Calibrator Kit3PMA Approval
- P060030COBAS AMPLIPREP/COBAS TAQMAN HCV TEST3PMA Approval
- P150015cobas HCV Test3PMA Approval
- P060030COBAS TaqMan HCV Test, v2.0, for Use with the High Pure System/COBAS AmpliPrep/COBAS TaqMan HCV Test, v2.03PMA Approval
- P150015Roche cobas HCV3PMA Approval
- P060030COBAS TaqMan HCV Test v2.0, For Use With High Pure System3PMA Approval
- P160023APTIMA HCV QUANT DX ASSAY3PMA Approval
- P100017ABBOTT REALTIME HCV3PMA Approval
- P150015COBAS HCV3PMA Approval
- P150015COBAS HCV TEST3PMA Approval
- P060030COBAS AmpliPrep/COBAS TaqMan HCV Test, v2.03PMA Approval
- P020011APTIMA HCV RNA QUALITATIVE ASSAY3PMA Approval
- P060030COBAS AMPLIPREP/COBAS TAQMAN HCV TEST3PMA Approval
- P060030COBAS AMPLIPREP/COBAS TAQMAN HCV TEST3PMA Approval
- P000012COBAS AMPLICOR HCV3PMA Approval
- P060030COBAS TAQMAN HCV3PMA Approval
- P150015COBAS HCV TEST3PMA Approval
- P100017ABBOTT REALTIME HCV ASSAY3PMA Approval
- P100017ABBOTT REALTIME HCV ASSAY, ABBOTT REALTIME HCV CALIBRATOR KIT, ABBOTT REALTIME HCV CONTROL KIT, ABBOTT MSAMPLE PREPARATI3PMA Approval
- P000012COBAS AMPLICOR (TM) HEPATITIS C VIRUS (HCV) TEST, V2.03PMA Approval
- P060030COBAS AMPLIPREP/COBAS TAQMAN HCV TEST3PMA Approval
- P150015COBAS HCV TEST3PMA Approval
- P060030COBAS AMPLIPREP/COBAS TAQMAN HCV TEST3PMA Approval
- P100017ABBOTT REALTIME HCV, ABBOTT REALTIME HCV AMPLIFICATION REAGENT KIT, ABBOTT REALTIME HVC CONTROL KIT, ABBOTT REALTIME HCV3PMA Approval
- P100017ABBOTT REALTIME HCV, ABBOTT REALTIME HCV AMPLIFICATION REAGENT KIT, ABBOTT REALTIME HVC CONTROL KIT, ABBOTT REALTIME HCV3PMA Approval
- P150015COBAS HCV TEST3PMA Approval
- P060030COBAS AMPLIPREP/COBAS TAQMAN HCV TEST V2.03PMA Approval
- P060030COBAS AMPLIPREP/ COBAS TAQMAN HCV TEST, V2.03PMA Approval
- P000012COBAS AMPLICOR HCV TEST VERSION 2.03PMA Approval
- P150015COBAS HCV TEST3PMA Approval
- P100017ABBOTT REALTIME HCV3PMA Approval
- P020011APTIMA HCV RNA QUALITATIVE ASSAY3PMA Approval
- P060030COBAS AMPLIPREP/COBAS TAQMAN HCV TEST V2.03PMA Approval
- P060030COBAS AMPLIPREP/COBAS TAQMAN HCV TEST, V2.03PMA Approval
- P100017ABBOTT REALTIME HCV ASSAY3PMA Approval
- P000012COBAS AMPLICOR HCV TEST , VERSION 2.03PMA Approval
- P060030COBAS AMPLIPREP/COBAS TAQMAN HCV TEST, COBAS TAQMAN HCV TEST,V2.0 FOR USE WITH THE HIGH PURE SYSTEM3PMA Approval
- P000012COBAS AMPLICOR HEPATITIS C VIRUS (HCV) TEST, VERSION 2.0 AND COBAS AMPLIPREP/COBAS AMPLICOR HCV TEST VERSION 2.03PMA Approval
- P000012COBAS AMPLICOR HEPATITIS C VIRUS (HCV) TEST, VERSION 2.0 AND COBAS AMPLIPREP/COBAS AMPLICOR HCV TEST, VERSION 2.03PMA Approval
- P060030COBAS TAQMAN HCV TEST FOR USE WITH THE HIGH PURE SYSTEM COBAS AMPLIPREP/COBAS TAQMAN HCV V2.03PMA Approval
- P100017ABBOTT REALTIME HCV ASSAY3PMA Approval
- P000012COBAS AMPLIPREP/COBAS AMPLICOR HCV TEST, VERSION 2.0, COBAS AMPLICOR HCV TEST, VERSION 2.03PMA Approval
- P100017ABBOTT REAL TIME HCV ASSAY, ABBOTT REAL TIME HCV CALIBRATOR KIT AND CONTROL KIT, ABBOTT MSAMPLE PREPARATION SYSTEM3PMA Approval
- P060030COBAS AMPLIPREP/COBAS TAQMAN HCV TEST, V2.03PMA Approval
- P060030COBAS AMPLIPREP/COBAS TAQMAN HCV TEST3PMA Approval
- P000012COBAS AMPLIPREP/COBAS AMPLICOR HCV TEST3PMA Approval
- P000012COBAS AMPLIPREP/COBAS AMPLICOR HCV TEST, V2.03PMA Approval
- P060030COBAS AMPLIPREP/COBAS TAQMAN HCV TEST, V2.03PMA Approval
- P060030COBAS AMPLIPREP/COMBAS TAQMAN HCV TEST V2.03PMA Approval
- P060030COBAS AMPLIPREP/ COBAS TAQMAN HCV TEST, V2.03PMA Approval
- P000012COBAS AMPLICOR HCV TEST V2.03PMA Approval
- P060030COBAS AMPLIPREP/COBAS TAQMAN HCV TEST3PMA Approval
- P020022VERSANT HCV RNA 3.0 ASSAY (BDNA)3PMA Approval
- P100017ABBOTT REALTIME HCV ASSAY3PMA Approval
- P100017ABBOTT REAL TIME HBV CALIBRATOR KIT3PMA Approval
- P000012COBAS AMPLIPREP/COBAS AMPLICOR HCV TEST3PMA Approval
- P060030COBAS AMPLIPREP/COBAS TAQMAN HCV TEST3PMA Approval
- P000012COBAS AMPLIPREP/COBAS AMPLICOR HCV TEST3PMA Approval
- P060030COBAS AMPLIPREP/COBAS TAQMAN HCV TEST3PMA Approval
- P100017ABBOTT REAL TIME HCV3PMA Approval
- P000012COBAS AMPLICOR HCV TEST, COBAS AMPLIPREP/COBAS AMPLICOR HCV TEST, VERSION 2.03PMA Approval
- P060030COBAS AMPLIPREP/COBAS TAQMAN HCV TEST, COBAS TAQMAN HCV TEST, V 2.0 FOR USE WITH THE HIGH PURE SYSTEM3PMA Approval
- P060030COBAS AMPLIPREP/COBAS TAQMAN HCV TEST VERSION 2.0, COBAS TAQMAN HCV TEST VERSION 2.0 FOR USE WITH THE HIGH PURE SYSTEM3PMA Approval
- P060030COBAS AMPLIPREP/COBAS TAQMAN HCV TEST,V2.0,; HIGH PURE/COBAS TAQMAN HCV V20.3 TEST3PMA Approval
- P100017ABBOTT REALTIME HCV3PMA Approval
- P000012COBAS AMPLIPREP/COBAS AMPLICOR HCV TEST, V2.03PMA Approval
- P000012COBAS AMPLICOR HCV TEST V2.0,COBAS AMPLIPREP/COBAS AMPLICOR HCV TEST3PMA Approval
- P060030COBAS AMPLIPREP/COBAS TAQMAN HCV TEST V2.03PMA Approval
- P000012COBAS AMPLIPREP/COBAS AMPLICOR HCV TEST, V2.03PMA Approval
- P100017ABBOTT REALTIME HCV3PMA Approval
- P020011VERSANT HCV RNA QUALITATIVE ASSAY/APTIMA HCV RNA QUALITATIVE ASSAY3PMA Approval
- P100017ABBOTT REALTIME HCV3PMA Approval
- P060030COBAS AMPLIPREP/COBAS TAQMAN HCV TEST, V2.03PMA Approval
- P060030COBAS AMPLIPREP / COBAS TAQMAN HCV TEST3PMA Approval
- P020011APTIMA HCV RNA QUALITATIVE ASSAY3PMA Approval
- P060030COBAS TAQMAN HCV TEST V2.0 FOR USE WITH THE HIGH PURE SYSTEM AND COBAS AMPLIPREP/BOBAS TAQMAN HCV TEST3PMA Approval
- P100017ABBOTT REALTIME HCV3PMA Approval
- P020022VERSANT HCV RNA 3.0 ASSAY (BDNA)3PMA Approval
- P060030COBAS AMPLIPREP/COBAS TAQMAN HCV V2.0 TEST FOR USE WITH THE HIGH PURE SYSTEM3PMA Approval
- P000012COBAS AMPLIPREP/COBAS AMPLICOR HCV TEST, VERSION 2.03PMA Approval
- P100017ABBOTT REALTIME HCV3PMA Approval
- P000012COBAS AMPLICOR HCV TEST, V2.0/COBAS AMPLIPREP/COBAS AMPLICOR HCV TEST V2.03PMA Approval
- P060030COBAS AMPLIPREP/COBAS TAQMAN HCV TEST/COBAS TAQMAN HCV TEST FOR USE WITH THE HIGH PURE SYSTEM, V2.03PMA Approval
- P060030COBAS AMPLIPREP/ COBAS TAQMAN HCV TEST3PMA Approval
- P000012COBAS AMPLICOR HCV TEST, V2.0, COBAS AMPLIPREP/COBAS AMPLICOR HCV TEST, VERSION 2.03PMA Approval
- P060030COBAS AMPLIPREP/COBAS TAQMAN HCV TEST3PMA Approval
- P060030COBAS AMPLIPREP / COBAS TAQMAN HCV TEST3PMA Approval
- P020011VERSANT HCV RNA QUALITATIVE ASSAY3PMA Approval
- P060030COBAS AMPLIPREP/COBAS TAQMAN HCV TEST AND COBAS TAQMAN HCV TEST FOR USE WITH THE HIGH PURE SYSTEM3PMA Approval
- P000012COBAS AMPLIPREP / COBAS AMPLICOR HCV V2.0 AND COBAS AMPLICOR HCV TEST, V2.03PMA Approval
- P060030COBAS TAQMAN HCV TESTS3PMA Approval
- P000012COBAS AMPLICOR HCV TEST V2.0, COBAS AMPLIPREP/ COBAS AMPLICOR HCV TEST, V2.03PMA Approval
- P000010AMPLICOR HCV TEST3PMA Approval
- P060030COBAS AMPLIPREP/COBAS TAQMAN HCV TEST AND COBAS TAQMAN HCV TEST3PMA Approval
- P000012COBAS AMPLICOR HCV TEST, V2.03PMA Approval
- P000010AMPLICOR HCV TEST V2.03PMA Approval
- P100017ABBOTT REALTIME HCV ASSAY3PMA Approval
- P000012COBAS AMPLIPREP/COBAS AMPLICOR HCV TEST V2.03PMA Approval
- P060030COBAS AMPLIPREP/COBAS TAQMAN HCV TEST3PMA Approval
- P000010AMPLICOR HCV TEST V2.0 & COBAS AMPLICOR HCV TEST V2.03PMA Approval
- P000012COBAS AMPLIPREP/COBAS AMPLICOR HCV TEST3PMA Approval
- P060030COBAS AMPLIPREP/COBAS TAQMAN HCV TEST3PMA Approval
- P000010AMPLICOR HCV TEST3PMA Approval
- P000012COBAS AMPLICOR HCV TEST3PMA Approval
- P000010AMPLICOR HCV TEST3PMA Approval
- P000012COBAS AMPLICOR HCV TEST/COBAS AMPLIPREP/COBAS AMPLICOR HCV TEST3PMA Approval
- P000012COBAS AMPLIPREP/COBAS AMPLICOR HCV TEST3PMA Approval
- P100017ABBOTT REALTIME HCV, ABBOTT REALTIME HCV AMPLIFICATION REAGENT KIT, ABBOTT REALTIME HVC CONTROL KIT, ABBOTT REALTIME HCV3PMA Approval
- P060030COBAS AMPLIPREP/COBAS TAQMAN HCV TEST3PMA Approval
- P000010AMPLICOR HCV TEST V2.0/COBAS AMPLICOR HCV TEST V2.03PMA Approval
- P000012COBAS AMPLIPREP/COBAS AMPLICOR HCV TEST V2.03PMA Approval
- P060030COBAS AMPLIPREP/COBAS TAQMAN HCV TEST3PMA Approval
- P060030COBAS TAQMAN HCV TEST V2.0 FOR USE WITH THE HIGH PURE SYSTEM3PMA Approval
- P000012COBAS AMPLIPREP/COBAS AMPLICOR HCV TEST3PMA Approval
- P000010AMPLICOR HCV/COBAS AMPLICOR HCV TEST3PMA Approval
- P000010AMPLICOR HCV TEST3PMA Approval
- P000012COBAS AMPLIPREP/COBAS AMPLICOR HVC TEST3PMA Approval
- P060030COBAS AMPLIPREP/COBAS TAQMAN HCV TEST3PMA Approval
- P020011VERSANT HCV RNA QUALITATIVE ASSAY/APTIMA HCV RNA QUALITATIVE ASSAY3PMA Approval
- P020011VERSANT & APTIMA HCV RNA QUALITATIVE ASSAY3PMA Approval
- P060030COBAS TAQMAN HCV TEST VERSION 2.03PMA Approval
- P060030COBAS AMPLIPREP/COBAS TAQMAN HCV TEST3PMA Approval
- P060030COBAS AMPLIPREP/COBAS TAQMAN HCV TEST3PMA Approval
- P020011VERSANT HCV RNA QUALITATIVE ASSAY/APTIMA HCV RNA QUALITATIVE ASSAY3PMA Approval
- P000010AMPLICOR HCV TEST, VERSION 2.03PMA Approval
- P060030COBAS AMPLIPREP/COBAS TAQMAN HCV TEST3PMA Approval
- P000012COBAS AMPLICOR HCV TEST AND COBAS AMPLIPREP/COBAS AMPLICOR HCV TEST VERSION 2.03PMA Approval
- P000010AMPLICOR HCV TEST3PMA Approval
- P060030COBAS AMPLIPREP/COBAS TAQMAN HCV TEST3PMA Approval
- P000012COBAS AMPLICOR HCV TEST3PMA Approval
- P000012COBAS AMPLIPREP/COBAS AMPLICOR HCV TEST3PMA Approval
- P060030COBAS AMPLIPREP/COBAS TAQMAN HCV TEST3PMA Approval
- P020022VERSANT HCV RNA 3.0 ASSAY (BDNA)3PMA Approval
- P060030COBAS AMPLIPREP / COBAS TAQMAN HCV TEST3PMA Approval
- P000012COBAS AMPLICOR HCV TEST/COBAS AMPLIPREP3PMA Approval
- P060030COBAS AMPLIPREP/COBAS TAQMAN HCV TEST3PMA Approval
- P000010AMPLICOR HCV TEST3PMA Approval
- P020011VERSANT HCV RNA QUALITATIVE ASSAY AND THE APTIMA HCV RNA QUALITATIVE ASSAY3PMA Approval
- P060030COBAS AMPLIPREP/COBAS TAQMAN HCV TEST3PMA Approval
- P020022VERSANT HCV RNA 3.0 ASSAY (BDNA)3PMA Approval
- P020022VERSANT HCV RNA 3.0 (BDNA) WITH VERSANT 440 MOLECULAR SYSTEM3PMA Approval
- P000012COBAS AMPLICOR HCV TEST, VERSION 2.03PMA Approval
- P000010AMPLICOR HCV TEST VERSION 2.03PMA Approval
- P000012COBAS AMPLIPREP/COBAS AMPLICOR HCV TEST3PMA Approval
- P060030COBAS AMPLIPREP/COBAS TAQMAN HCV TEST3PMA Approval
- P060030COBAS AMPLIPREP/COBAS TAQMAN HCV TEST3PMA Approval
- P000012ROCHE MOLECULAR SYSTEMS COBAS AMPLIPREP/COBAS AMPLICOR HCV TEST3PMA Approval
- P060030COBAS AMPLIPREP/COBAS TAQMAN HCV TEST3PMA Approval
- P000012COBAS AMPLIPREP/COBAS AMPLICOR HCV TEST3PMA Approval
- P000012COBAS AMPLICOR HCV TEST3PMA Approval
- P000010AMPLICOR HCV TEST3PMA Approval
- P000010AMPLICOR HCV TEST, VERSION 2.03PMA Approval
- P000012COBAS AMPLICOR HCV TEST, VERSION 2.03PMA Approval
- P000010AMPLICOR HEPATITIS C VIRUS (HCV) TEST3PMA Approval
- P000012COBAS AMPLICOR HEPATITIS C VIRUS (HCV) TEST3PMA Approval
- P020022VERSANT HCV RNA 3.0 ASSAY (BDNA)3PMA Approval
- P000010AMPLICOR HCV TEST VERSION 2.03PMA Approval
- P000012COBAS AMPLICOR HCV TEST VERSION 2.03PMA Approval
- P020022BAYER VERSANT HCV RNA 3.0 ASSAY (BDNA)3PMA Approval
- P000012COBAS AMPLICOR HEPTATIS C VIRUS (HCV) TEST3PMA Approval
- P000010AMPLICOR HEPATITIS C VIRUS (HCV) TEST VERSION 2.03PMA Approval
- P000012COBAS AMPLICOR HEPATITIS C VIRUS (HCV) TEST, V2.03PMA Approval
- P020022BAYER VERSANT HCV RNA 3.0 ASSAY (BDNA)3PMA Approval
- P000012COBAS AMPLICOR HEPATITIS C VIRUS (HCV) TEST, VERSION 2.03PMA Approval
- P000010AMPLICOR HEPATITIS C VIRUS (HCV) TEST, VERSION 2.03PMA Approval
- P020022BAYER VERSANT HCV RNA 3.0 ASSAY (BDNA)3PMA Approval
- P000012COBAS AMPLICOR HCV TEST, VERSION 2.03PMA Approval
- P000012COBAS AMPLIPREP/COBAS AMPLICOR HCV TEST, VERSION 2.03PMA Approval
- P000010AMPLICOR HCV TEST, V2.03PMA Approval
- P000012COBAS AMPLICOR HCV TEST, VERSION 2.0 AND COBAS AMPLIPREP/COBAS AMPLICOR HCV TEST, VERSION 2.03PMA Approval
- P000010AMPLICOR HCV, TEST VERSION 2.03PMA Approval
- P020022BAYER VERSANT HCV RNA 3.0 ASSAY (BDNA)3PMA Approval
- P020022BAYER VERSANT HCV RNA 3.0 ASSAY (BDNA)3PMA Approval
- P000012COBAS AMPLICOR HCV TEST, VERSION 2.03PMA Approval
- P000012COBAS AMPLIPREP/COBAS AMPLICOR HCV TEST, VERSION 2.03PMA Approval
- P000010AMPLICOR HCV TEST,VERSION 2.03PMA Approval
- P020022BAYER VERSANT (TM) HCV RNA 3.0 ASSAY (BDNA)3PMA Approval
- P020011VERSANT HCV RNA QUALITATIVE ASSAY3PMA Approval
- P000012COBAS AMPLICOR HCV TEST, V2.03PMA Approval
- P000010AMPLICOR HEPATITIS C VIRUS (HCV) TEST VERSION 2.03PMA Approval
- P000012COBAS AMPLICOR (TM) HEPATITIS C VIRUS (HCV) TEST, V2.03PMA Approval
- NCDTest, Immunity, Cell Mediated, Mycobacterium Tuberculosis3Product Code
- NWYTest, Qualitative, Detection Of Dengue Igm And Igg AntibodiesNProduct Code
- QPODevice To Preserve And Stabilize Relative Abundances Of Microbial Nucleic Acids In Clinical Samples2Product Code
- LOMTest, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)3Product Code
- LQIHepatitis Delta Serological Reagents3Product Code
- MAQKit, Dna Detection, Human Papillomavirus3Product Code
- MHRTest, Anti-Tumor Cell Susceptibility3Product Code
- MKTHepatitis Viral B Dna Detection3Product Code
- MYLAssay,Enzyme Linked Immunosorbent,Parvovirus B19 Igg3Product Code
- MYMAssay,Enzyme Linked Immunosorbent,Parvovirus B19 Igm3Product Code
- MZOAssay, Enzyme Linked Immunosorbent, Hepatitis C Virus3Product Code
- OIHYersinia Spp. ReagentsUProduct Code
- OJNMycobacterium Tuberculosis, Cell Mediated Immune Response, Enzyme-Linked Immunospot Test3Product Code
- OJOEnzyme Linked Immunosorbent Assay For The Detection Of Lipoarabinomannan Antigen Of MycobacteriaNProduct Code
- ORLWhole Blood Pre-Treatment T-Cell Enrichment Reagent3Product Code
- OTTResearch Use Only/MicrobiologyNProduct Code
- OYBKit, Rna Detection, Human Papillomavirus3Product Code
- PABCytomegalovirus (Cmv) Dna Quantitative Assay3Product Code
- PCYInvestigational Use Only - MicrobiologyNProduct Code
- POAReagents, Zika Virus Nucleic AcidNProduct Code
- POGReagents, Ebola Zaire Virus (Detected In The West Africa Outbreak In 2014) Nucleic AcidNProduct Code
- PYSZika Virus Serological Reagents (Emergency Use)NProduct Code
- QHVMultiple Osteoarticular Pathogen Antigen KitNProduct Code
- QIMBartonella Spp. Serological ReagentsNProduct Code
- QINBabesia Spp. Serological ReagentsNProduct Code
- QIOAnaplasma Spp. And Ehrlichia Spp. Serological ReagentsNProduct Code
- QIPRickettsia Spp. (Spotted Fever Group Or Typhus Group) Serological ReagentsNProduct Code
- QIQOrientia Spp. (Scrub Typhus) Serological ReagentsNProduct Code
- QJRReagents, 2019-Novel Coronavirus Nucleic AcidNProduct Code
- QKOReagent, Coronavirus SerologicalNProduct Code
- QKPCoronavirus Antigen Detection Test System.NProduct Code
- QLTCovid-19 Multi-Analyte Respiratory Panel Nucleic Acid DevicesNProduct Code
- QLWCovid-19 Test Home Collection Kit DevicesNProduct Code
- QMNCovid-19 Multi-Analyte Antigen DeviceNProduct Code
- QSHCoronavirus Marker DetectionNProduct Code
- QSNOrthopedic Infection Microbial Multiplex Nucleic Acid Detection System2Product Code
- QSSHiv Self-Tests3Product Code
- QTANgs Whole Genome Sequencing For Sars-Cov-2 Genetic AnalysisNProduct Code
- QTPReagents, Monkeypox Virus Nucleic Acid.NProduct Code
- QTQReagents, Non-Variola Orthopoxvirus Nucleic Acid.NProduct Code
- QWBOver-The-Counter Molecular Test To Detect Sars-Cov-2 From Clinical Specimens2Product Code
- QVRMultiplex Nucleic Acid Detection System For Biothreat Agents2Product Code
- QUUSimple In Vitro Diagnostic Device For The Detection Of Secreted Proteins From Bacillus Spp. In Human Clinical Samples2Product Code
- QVFSimple Point-Of-Care Device To Directly Detect Sars-Cov-2 Viral Targets From Clinical Specimens In Near-Patient Settings2Product Code
- QVPSars-Cov-2 Serology Test2Product Code
- QWRSimple Point-Of-Care Device To Detect Sar-Cov-2 Nucleic Acid Targets From Clinical Specimens In Near-Patient Settings2Product Code
- QYASystem For Detection Of Nucleic Acid From Non-Viral Microorganism(S) Causing Stis Using Specimens Collected At Home2Product Code
- QYTOver-The-Counter Covid-19 Antigen Test2Product Code
- SBPSimple Point-Of-Care Nucleic Acid-Based Hepatitis C Virus Ribonucleic Acid Test2Product Code
- SBTDevice To Detect Microbial Colonization Directly From Clinical Specimens.2Product Code
- SBZTest For Detection Of Antibodies Associated With Syphilis Performed By Lay Users2Product Code
- SCAMulti-Analyte Respiratory Virus Antigen Detection Test2Product Code
- SDMNucleic Acid Test Used For Screening Of Cadaveric (Non-Heart-Beating) Donors Of Blood Or Blood Products Or Hct/PsUProduct Code
- SDNSerology Test Used For Screening Of Cadaveric (Non-Heart-Beating) Donors Of Blood Or Blood Products Or Hct/PsUProduct Code
- SEATest For Detection Of Microorganism(S) Causing Sexually Transmitted Infections Performed By Lay Users2Product Code
- SEPDevice For Home Collection And Transport Of Vaginal Specimens By Lay Users For Use In An Approved Hpv Molecular Assay2Product Code
- SGABiothreat Microbial Agent Nucleic Acid Detection Test2Product Code
- QTUReagents, Non-Variola Orthopoxvirus Or Monkeypox Virus Singleplex Antigen TestsNProduct Code
- Submissions with No Product CodeMiscellaneous
- Subpart B—Biological StainsCFR Sub-Part
- Subpart B—Clinical Chemistry Test SystemsCFR Sub-Part
- Subpart B—Diagnostic DevicesCFR Sub-Part
- Subpart C—Clinical Laboratory InstrumentsCFR Sub-Part
- Subpart C—Microbiology DevicesCFR Sub-Part
- Subpart D—Serological ReagentsCFR Sub-Part
- Subpart F—Immunological Test SystemsCFR Sub-Part
- NeurologyReview Panel
- Obstetrical and GynecologicalReview Panel
- OphthalmicReview Panel
- OrthopedicReview Panel
- PathologyReview Panel
- Physical MedicineReview Panel
- RadiologyReview Panel
- General and Plastic SurgeryReview Panel
- ToxicologyReview Panel
- Medical GeneticsReview Panel
- UnknownReview Panel
Aptima HCV RNA Qualitative Assay
- Page Type
- PMA Approval
- Full PDF / Letter* The FDA doesn't provide PDFs for all submissions.
- Applicant
- GEN-PROBE
- Trade Name
- VERSANT HCV RNA QUALITATIVE ASSAY
- Generic Name
- Assay, hybridization and/or nucleic acid amplification for detection of hepatitis c rna,hepatitis c virus
- Decision Date
- 11/7/2002
- Days to Decision
- 234 days
- Decision Code
- APPR
- FDA Decision
- Approval