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- MiscellaneousMiscellaneous
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- OBFAssay, Genotyping, Hepatitis C Virus3Product Code
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- 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
- 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
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- 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
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- PYSZika Virus Serological Reagents (Emergency Use)NProduct Code
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- 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
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- QTQReagents, Non-Variola Orthopoxvirus Nucleic Acid.NProduct Code
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- SDNSerology Test Used For Screening Of Cadaveric (Non-Heart-Beating) Donors Of Blood Or Blood Products Or Hct/PsUProduct Code
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- QTUReagents, Non-Variola Orthopoxvirus Or Monkeypox Virus Singleplex Antigen TestsNProduct Code
- SGWDevice To Detect Antibodies To Hepatitis D Virus2Product Code
- Submissions with No Product CodeMiscellaneous
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- K842400BIOTIS N.Y.C. CARBOHYDRATE FERMENTA-Cleared 510(K)
- P990041ETI-AB-EBK PLUS assayOK30PMA Approval
- P990041ETI-AB-EBK PLUS assayOK30PMA Approval
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- P990044ETI-CORE-IGMK PLUS assayOK30PMA Approval
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- P990044ETI-CORE-IGMK PLUS assayOK30PMA Approval
- P990045ETI-AB-COREK PLUS assayOK30PMA Approval
- P990044ETI-CORE-IGMK Plus AssayOK30PMA Approval
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- P990045ETI-AB-COREK PLUS AssayOK30PMA Approval
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- P990041ETI-AB-EBK PLUS assayOK30PMA Approval
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- P050028COBAS TAQMAN HBV TEST FOR USE WITH THE HIGH PURE SYSTEMOK30PMA Approval
- P050028COBAS TAQMAN HBV TEST FOR USE WITH THE HIGH PURE SYSTEMOK30PMA Approval
- P050028COBAS TAQMAN HBV TEST FOR USE WITH THE HIGH PURE SYSTEMOK30PMA Approval
- P050028COBAS TAQMAN HBV TESTOK30PMA Approval
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- P990044DIASORIN ETI-CORE-IGMK PLUS ASSAYAPPRPMA Approval
- P990045DIASORIN ETI-AB-COREK PLUS ASSAYAPPRPMA Approval
- P990041DIASORIN ETI-AB-EBK PLUS ASSAYAPPRPMA Approval
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- P940034GEN-PROBE(R) AMPLIFIED MYCOBACTERIUM TUBERCULOSIS DIRECT TEST (MTD TEST)APPRPMA Approval
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- P940034AMPLIFED MYCOBACTERIUM TUBERCULOSIS DIRECTOR (MTD) TESTAPPRPMA Approval
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- K841660SELENITE CYSTINE BROTH BASECleared 510(K)
- K841915PHAMAS ALLERGY MGMT. SYSTEMCleared 510(K)
- K840851VIRAL TRANSPORT MEDIUMCleared 510(K)
- K833292LACTABACILLUS AGAR W/O TWEEN80Cleared 510(K)
- K833027HAEMOPHILUS/NEISSERIA IDENTIF-PANELCleared 510(K)
- K833214DEXTROSECleared 510(K)
- K832934MACCONKEY'S AGAR PLATECleared 510(K)
- K830646DIRECTIGEN NEISSERIA MENINGITIDISCleared 510(K)
- K822518CSM BETA-LACTAMASE DISCCleared 510(K)
- K820208ZYME ACleared 510(K)
- K812123CYTOMEGELISA TEST KITCleared 510(K)
- K800052ANTIMICROBIAL REMOVAL DEVICE (ARD)Cleared 510(K)
- K781283READER, INOCULUM, STDIZED.Cleared 510(K)
- K781097INOCULUM STDIZING SYS., INOCUPACCleared 510(K)
- K780114IMMUNOZYME E. HISTOLYTICA ANTIGENSCleared 510(K)
- K771569AUTOSTREAKERCleared 510(K)
- K760356DISH, STERILE DISPOSABLE POLYSTYRENECleared 510(K)
- K760583DISPOSABLE/BOROSILICATE CULTURE TUBESCleared 510(K)
- N17578INDIRECT FLUORESCENT-ANTIBODY TEST FOR GONORRHEA (IFA-GC)APPRPMA Approval
- 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
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GEN-PROBE AMPLIFIED MYCOBACTERIUM TUBERCULOSIS DIRECT TEST
- Page Type
- PMA Approval
- PDF* The FDA doesn't provide PDFs for all submissions.
- Applicant
- GEN-PROBE, INC.
- Trade Name
- GEN-PROBE(R) AMPLIFIED MYCOBACTERIUM TUBERCULOSIS DIRECT TEST (MTD TEST)
- Generic Name
- System, nucleic acid amplification, mycobacterium tuberculosis complex
- Decision Date
- 12/15/1995
- Days to Decision
- 522 days
- Decision Code
- APRL
- FDA Decision
- Reclassification after approval