Anesthesiology
Review Panel
- CardiovascularReview Panel
- ChemistryReview Panel
- DentalReview Panel
- Ear, Nose, ThroatReview Panel
- Gastroenterology and UrologyReview Panel
- General HospitalReview Panel
- HematologyReview Panel
- ImmunologyReview Panel
- MiscellaneousMiscellaneous
- Subpart C—Clinical Laboratory InstrumentsCFR Sub-Part
- Subpart C—Microbiology DevicesCFR Sub-Part
- Subpart D—Clinical Toxicology Test SystemsCFR Sub-Part
- Subpart D—Serological ReagentsCFR Sub-Part
- Subpart E—Immunology Laboratory Equipment and ReagentsCFR Sub-Part
- Subpart E—Specimen Preparation ReagentsCFR Sub-Part
- Subpart F—Automated and Semi-Automated Hematology DevicesCFR Sub-Part
- Subpart F—Immunological Test SystemsCFR Sub-Part
- CZQBence-Jones Protein, Antigen, Antiserum, Control2Product Code
- CZRHemopexin, Rhodamine, Antigen, Antiserum, Control2Product Code
- CZSRetinol-Binding Protein, Antigen, Antiserum, Control1Product Code
- CZTHemopexin, Fitc, Antigen, Antiserum, Control2Product Code
- CZWComplement C3, Antigen, Antiserum, Control2Product Code
- CZXHemopexin, Antigen, Antiserum, Control2Product Code
- CZYComplement C1s, Antigen, Antiserum, Control2Product Code
- CZZHaptoglobin, Rhodamine, Antigen, Antiserum, Control2Product Code
- DABHaptoglobin, Fitc, Antigen, Antiserum, Control2Product Code
- DACComplement C3b Activator, Antigen, Antiserum, Control2Product Code
- DADHaptoglobin, Antigen, Antiserum, Control2Product Code
- DAEComplement C9, Antigen, Antiserum, Control2Product Code
- DAFGamma Globulin, Fitc, Antigen, Antiserum, Control2Product Code
- DAGComplement C8, Antigen, Antiserum, Control2Product Code
- DAHGamma Globulin, Antigen, Antiserum, Control2Product Code
- DAIComplement C1r, Antigen, Antiserum, Control2Product Code
- DAJFree Secretory Component, Antigen, Antiserum, Control2Product Code
- DAKComplement C1q, Antigen, Antiserum, Control2Product Code
- DALFraction Iv-5, Antigen, Antiserum, Control1Product Code
- DAMHemoglobin, Chain Specific, Antigen, Antiserum, Control2Product Code
- DANFibrinopeptide A, Antigen, Antiserum, Control2Product Code
- DAOIgm (Mu Chain Specific), Antigen, Antiserum, Control2Product Code
- DAQIgg (Fd Fragment Specific), Antigen, Antiserum, Control1Product Code
- DASIgg (Fc Fragment Specific), Antigen, Antiserum, Control1Product Code
- CFFImmunoelectrophoretic, Immunoglobulins, (G, A, M)2Product Code
- CFNMethod, Nephelometric, Immunoglobulins (G, A, M)2Product Code
- CFQRadioimmunoassay, Immunoglobulins (G, A, M)2Product Code
- CGMMethod, Immunodiffusion, Immunoglobulins (G, A, M)2Product Code
- CHNImmunochemical, Ceruloplasmin2Product Code
- CZJIgd, Antigen, Antiserum, Control2Product Code
- CZKIga, Rhodamine, Antigen, Antiserum, Control2Product Code
- CZLIga, Peroxidase, Antigen, Antiserum, Control2Product Code
- CZMIga, Ferritin, Antigen, Antiserum, Control2Product Code
- CZNIga, Fitc, Antigen, Antiserum, Control2Product Code
- CZOInter-Alpha Trypsin Inhibitor, Antigen, Antiserum, Control1Product Code
- CZPIga, Antigen, Antiserum, Control2Product Code
- DAWAlpha-2-Ap-Glycoprotein, Antigen, Antiserum, Control1Product Code
- DAYComplement C5, Antigen, Antiserum, Control2Product Code
- DBAComplement C1 Inhibitor (Inactivator), Antigen, Antiserum, Control2Product Code
- DBCAlpha 2, 2n-Glycoprotein, Antigen, Antiserum, Control1Product Code
- DBEAntismooth Muscle Antibody, Indirect Immunofluorescent, Antigen, Control2Product Code
- DBFFerritin, Antigen, Antiserum, Control2Product Code
- DBHFc, Rhodamine, Antigen, Antiserum, Control1Product Code
- DBIComplement C4, Antigen, Antiserum, Control2Product Code
- DBJAntiparietal Antibody, Indirect Immunofluorescent, Antigen, Control2Product Code
- DBKFc, Fitc, Antigen, Antiserum, Control1Product Code
- DBLMultiple Autoantibodies, Indirect Immunofluorescent, Antigen, Control2Product Code
- DBMAntimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control2Product Code
- DBNFc, Antigen, Antiserum, Control1Product Code
- DBYFab, Rhodamine, Antigen, Antiserum, Control1Product Code
- DCBFab, Fitc, Antigen, Antiserum, Control1Product Code
- DCEFab, Antigen, Antiserum, Control1Product Code
- DCFAlbumin, Antigen, Antiserum, Control2Product Code
- DCHSystem, Test, C-Reactive Protein, Rhodamine2Product Code
- DCJBeta-Globulin, Antigen, Antiserum, Control1Product Code
- DCKC-Reactive Protein, Antigen, Antiserum, And Control2Product Code
- DCNSystem, Test, C-Reactive Protein2Product Code
- DCOAlpha-Globulin, Antigen, Antiserum, Control1Product Code
- DCTCeruloplasmin, Rhodamine, Antigen, Antiserum, Control2Product Code
- DCYCeruloplasmin, Fitc, Antigen, Antiserum, Control2Product Code
- DDBCeruloplasmin, Antigen, Antiserum, Control2Product Code
- DDCThyroglobulin, Antigen, Antiserum, Control2Product Code
- DDDTransferrin, Rhodamine, Antigen, Antiserum, Control2Product Code
- DDGTransferrin, Antigen, Antiserum, Control2Product Code
- DDITransferrin, Fitc, Antigen, Antiserum, Control2Product Code
- DDJThyroglobulin, Fitc, Antigen, Antiserum, Control2Product Code
- DDKBeta-2-Glycoprotein Iii, Antigen, Antiserum, Control1Product Code
- DDLThyroglobulin, Rhodamine, Antigen, Antiserum, Control2Product Code
- DDNBeta-2-Glycoprotein I, Antigen, Antiserum, Control1Product Code
- DDOMyoglobin, Rhodamine, Antigen, Antiserum, Control2Product Code
- DDRMyoglobin, Antigen, Antiserum, Control2Product Code
- DDSPrealbumin, Fitc, Antigen, Antiserum, Control1Product Code
- DDTAlpha-2-Macroglobulin, Rhodamine, Antigen, Antiserum, Control2Product Code
- DDYAlpha-2-Macroglobulin, Fitc, Antigen, Antiserum, Control2Product Code
- DDZAlbumin, Fitc, Antigen, Antiserum, Control2Product Code
- DEAMyoglobin, Fitc, Antigen, Antiserum, Control2Product Code
- DEBAlpha-2-Macroglobulin, Antigen, Antiserum, Control2Product Code
- DECInter-Alpha Trypsin Inhibitor, Fitc, Antigen, Antiserum, Control1Product Code
- DEFAlpha-2-Hs-Glycoprotein, Antigen, Antiserum, Control1Product Code
- DEGLactoferrin, Antigen, Antiserum, Control1Product Code
- DEHLambda, Antigen, Antiserum, Control2Product Code
- DEIAlpha-1-Antitrypsin, Fitc, Antigen, Antiserum, Control2Product Code
- DEJAlpha-2-Glycoproteins, Antigen, Antiserum, Control1Product Code
- DEKKappa, Rhodamine, Antigen, Antiserum, Control2Product Code
- DELLipoprotein X, Antigen, Antiserum, Control1Product Code
- DEMAlpha-1-Antitrypsin, Antigen, Antiserum, Control2Product Code
- DENAlpha-1-T-Glycoprotein, Antigen, Antiserum, Control1Product Code
- DEOKappa, Fitc, Antigen, Antiserum, Control2Product Code
- DERAlpha-1-Lipoprotein, Antigen, Antiserum, Control2Product Code
- DESLambda, Fitc, Antigen, Antiserum, Control2Product Code
- DETLactic Dehydrogenase, Antigen, Antiserum, Control1Product Code
- DEWIgg, Antigen, Antiserum, Control2Product Code
- K050113TINA-QUANT IGG GEN.22Cleared 510(K)
- K040434ROCHE DIAGNOSTICS TINA-QUANT IGG GEN.22Cleared 510(K)
- K010617SPIFE IFE CALIBRATOR AND CONTROL KIT2Cleared 510(K)
- K993928WAKO-IGG II-HA, IMMUNOGLOBULIN CALIBRATOR SET, IMMUNOLOBULIN STANDARD2Cleared 510(K)
- K993281K-ASSAY IGG2Cleared 510(K)
- K983221IGG2Cleared 510(K)
- K965108SYNCHRON LX SYSTEMS IMMUNOGLOBULIN G/A/M REAGENT2Cleared 510(K)
- K963974IMAGE-IMMUNOCHEMISTRY SYSTEM URINE IMMUNOGLOBULIN2Cleared 510(K)
- K963868IMMAGE IMMUNOCHEMISTRY SYSTEM IMMUNOGLOBULIN G (IGG), A (IGA) AND M (IGM)2Cleared 510(K)
- K962202QUANTEX IGG2Cleared 510(K)
- K955798IGG IMMUNOTURBIDIMETRIC & CALIBRATOR2Cleared 510(K)
- K951635BECKMAN IMMUNOGLOBULIN G (IGG) REAGENT, URINE APPLICATION, URINE PROTEIN CALIBRATOR, CONTROL2Cleared 510(K)
- K943997BEHRING NEPHELOMETER II2Cleared 510(K)
- K934324OT IGG SORBENT2Cleared 510(K)
- K933314RADIAS FERRITIN ENZYME IMMUNOASSAY2Cleared 510(K)
- K924197ZORBA(TM) IGG REMOVAL REAGENT2Cleared 510(K)
- K921575IGG SUCLASS EIA2Cleared 510(K)
- K911610ELISA COMBI-KIT HUMAN IGG SUBCLASSES2Cleared 510(K)
- K900943MODIFIED TECHNICON DPA-1(TM) SYSTEM2Cleared 510(K)
- K893419COULTER CLONE GAM-FITC POLY ANTI (IGG & IGM)2Cleared 510(K)
- K891385VITEK IMMUNODIAGNOSTIC ASSAY SYSTEM (VIDAS)2Cleared 510(K)
- K890416SPQ(TM) ANTIBODY REAGENT SET II FOR IGG2Cleared 510(K)
- K882369ACCRAASSAY RID KITS2Cleared 510(K)
- K882083QM300 IGG ANTIBODY PACK2Cleared 510(K)
- K880784WAKO(TM) IGG-HA DIRECT2Cleared 510(K)
- K875254GULLSORB IGG INACTIVATION REAGENT2Cleared 510(K)
- K875356IMMUNOGLOBULIN G & G SUBCLASSES2Cleared 510(K)
- K873870IMMUNOGLOBULINS G2Cleared 510(K)
- K872800TDX IMMUNOGLOBULIN G DIAGNOSTIC KIT2Cleared 510(K)
- K871352PENTAVALENT ANTISERUM TO HUMAN IMMUNOGLOBULINS2Cleared 510(K)
- K871340QM300 IGG ANTIBODY PACK2Cleared 510(K)
- K862764TINA-QUANT(R) IGG2Cleared 510(K)
- K861059DAKO ITA SYSTEM2Cleared 510(K)
- K853465GILFORD IMMUNOGLOBULIN G REAGENT2Cleared 510(K)
- K852589TDX IMMUNOGLOBULIN G DIAGNOSTIC KIT2Cleared 510(K)
- K851541DART IMMUNOGLOBULINS REAGENT SYSTEM2Cleared 510(K)
- K850583SPQ TEST SYSTEM FOR IMMUNOGLOBULIN G2Cleared 510(K)
- K842329AMER. HISTO-ID SYS PRIMARY IGG S7920-112Cleared 510(K)
- K841816OPTIMATE IGG TEST2Cleared 510(K)
- K833402TECH. RA-1000SYS-ANALYTES IMMUNOGLOBULIN2Cleared 510(K)
- K832258GOAT ANTI-HUMAN IGG Y CHAIN SPECIFIC2Cleared 510(K)
- K832264FITC GOAT ANTI-HUMAN IGG Y CHAIN2Cleared 510(K)
- K831101TIA-IGG REAGENT & CALIBRATOR SETS2Cleared 510(K)
- K830594TITAN IMMUNO-FIX2Cleared 510(K)
- K821018ANTIHUMAN IGG GLOBULIN FITC LABELED2Cleared 510(K)
- K812484DAKO PAP KIT K5052Cleared 510(K)
- K812664ACA IMMUNOGLOBULIN G ANALYTICAL TEST2Cleared 510(K)
- K812630ACA IMMUNOGLOBULIN G CALIBRATOR2Cleared 510(K)
- K812489IMMUNOGL. FRCT. OF RABBIT ANTISER.-IGG2Cleared 510(K)
- K812495IMMUNOGL. FRCT. OF RABBIT ANTISER.-ALPHA2Cleared 510(K)
- K812453SCRIPPSYSTEM IMMUNOGLOBIN RID KIT2Cleared 510(K)
- K812328SCRIPPSYSTEM NEPHELOMETRIC ANTISERA KIT2Cleared 510(K)
- K810694PHADEBAS IGG RAST TEST2Cleared 510(K)
- K811126AIM SYSTEM (FOR IGG)2Cleared 510(K)
- K810056IMMUNOLOGY CONTROL SERUM2Cleared 510(K)
- K802257GOAT ANTI-HUMAN IGG GAMMA CHAIN SPECIFIC2Cleared 510(K)
- K801281J.T. BAKER IMMUNOGLOBULIN G NEPHELOMETRI2Cleared 510(K)
- K800897RID SYSTEM-QUAD MULTITEST IGG, IGA,ETC.2Cleared 510(K)
- K800451GEMENI IGG ASSAY2Cleared 510(K)
- K800398PARACONTROL ABNORMAL IMMUNOGLOBULIN CONT2Cleared 510(K)
- K800119IMMUNOGLOBULIN G REAGENT SYSTEM2Cleared 510(K)
- K791281ANTI-HUMAN IGG SERUM2Cleared 510(K)
- K791824ANTISERUM TO HUMAN IMMUNOGLOBULINS2Cleared 510(K)
- K791403LANCER L-INA ANTI-IGG2Cleared 510(K)
- K791285ANTI-HUMAN GLOBULINS2Cleared 510(K)
- K790702ANTISERUM, HUMAN, IGG H & L CHAIN2Cleared 510(K)
- K790704ANTISERUM TO HUMAN IGG2Cleared 510(K)
- K772077RADIAL IMMUNODIFFUSION KIT-IMMUNOGLOB.G2Cleared 510(K)
- K772252IMMUNOGLOBULIN G NEPHEL. ASSAY2Cleared 510(K)
- K770961GOAT ANTISERUM IGG NEPHELOMETRIC2Cleared 510(K)
- K770669RHODAMINE-CONJUGATED ANTISERUM2Cleared 510(K)
- K770668FLUORESCEIN CONJUGATED ANTISERUM2Cleared 510(K)
- K770597DASP TM ANTI-RABBIT2Cleared 510(K)
- K761224ULTRA LOW LEVEL IMMUNOGLOBULIN G2Cleared 510(K)
- K770484FLUOR. CONJUGATED ANTISERUM2Cleared 510(K)
- K760145SERUM, IGG GOAT ANTI-HUMAN ACID2Cleared 510(K)
- DEXAlpha-1-B-Glycoprotein, Antigen, Antiserum, Control1Product Code
- DEZIgm, Rhodamine, Antigen, Antiserum, Control2Product Code
- DFBAlpha-1-Antitrypsin, Rhodamine, Antigen, Antiserum, Control2Product Code
- DFCLipoprotein, Low-Density, Antigen, Antiserum, Control2Product Code
- DFFAlpha-1-Antichymotrypsin, Antigen, Antiserum, Control2Product Code
- DFGLambda, Rhodamine, Antigen, Antiserum, Control2Product Code
- DFHKappa, Antigen, Antiserum, Control2Product Code
- DFITotal Spinal-Fluid, Antigen, Antiserum, Control1Product Code
- DFJAlbumin, Rhodamine, Antigen, Antiserum, Control2Product Code
- DFKIgg (Fab Fragment Specific), Antigen, Antiserum, Control1Product Code
- DFLIgm, Ferritin, Antigen, Antiserum, Control2Product Code
- DFMIge, Ferritin, Antigen, Antiserum, Control2Product Code
- DFOIgg, Rhodamine, Antigen, Antiserum, Control2Product Code
- DFQSperm, Antigen, Antiserum, Control1Product Code
- DFSIgm, Fitc, Antigen, Antiserum, Control2Product Code
- DFTIgm, Antigen, Antiserum, Control2Product Code
- DFXSperm, Fitc, Antigen, Antiserum, Control1Product Code
- DFZIgg (Gamma Chain Specific), Antigen, Antiserum, Control2Product Code
- DGACohn Fraction Ii, Antigen, Antiserum, Control1Product Code
- DGCIge, Antigen, Antiserum, Control2Product Code
- DGDIgg, Ferritin, Antigen, Antiserum, Control2Product Code
- DGEIgd, Rhodamine, Antigen, Antiserum, Control2Product Code
- DGGIgd, Fitc, Antigen, Antiserum, Control2Product Code
- DGIBreast Milk, Rhodamine, Antigen, Antiserum, Control1Product Code
- DGJColostrum, Antigen, Antiserum, Control1Product Code
- DGKIgg, Fitc, Antigen, Antiserum, Control2Product Code
- DGLIge, Rhodamine, Antigen, Antiserum, Control2Product Code
- DGMBreast Milk, Antigen, Antiserum, Control1Product Code
- DGNBreast Milk, Fitc, Antigen, Antiserum, Control1Product Code
- DGPIge, Fitc, Antigen, Antiserum, Control2Product Code
- DGWSystem, Test, Hypersensitivity Pneumonitis2Product Code
- DGXNg1m(A), Antigen, Antiserum, Control1Product Code
- DHBSystem, Test, Radioallergosorbent (Rast) Immunological2Product Code
- DHCSystem, Test, Systemic Lupus Erythematosus2Product Code
- DHINg3m(Bo), Antigen, Antiserum, Control1Product Code
- DHNAntinuclear Antibody, Indirect Immunofluorescent, Antigen, Control2Product Code
- DHQNg3m(G), Antigen, Antiserum, Control1Product Code
- DHRSystem, Test, Rheumatoid Factor2Product Code
- DHYNg4m(A), Antigen, Antiserum, Control1Product Code
- JFQP-Phenyl-Enediamine/Edta (Spectrophotometric), Ceruloplasmin2Product Code
- JFRIndirect Copper Assay, Ceruloplasmin2Product Code
- JHRRadioimmunoassay, Immunoglobulins (D, E)2Product Code
- JKMImmunochemical, Bence-Jones Protein2Product Code
- JNLImmunochemical, Thyroglobulin Autoantibody2Product Code
- JNMImmunochemical, Transferrin2Product Code
- JZGSystem, Test, Beta-2-Microglobulin Immunological2Product Code
- JZHFactor B, Antigen, Antiserum, Control2Product Code
- JZJPrealbumin, Antigen, Antiserum, Control1Product Code
- JZOSystem, Test, Thyroid Autoantibody2Product Code
- KHTFraction V, Antigen, Antiserum, Control1Product Code
- KTLAnti-Dna Indirect Immunofluorescent Solid Phase2Product Code
- KTMC3-Indirect Immunofluorescent Solid Phase2Product Code
- KTOReagent, Immunoassay, Igg1Product Code
- KTPComplement C3b Activator Immunoassay Reagents2Product Code
- KTSSecond Antibody (Species Specific Anti-Animal Gamma Globulin)2Product Code
- LJMAntinuclear Antibody (Enzyme-Labeled), Antigen, Controls2Product Code
- LKJAntinuclear Antibody, Antigen, Control2Product Code
- LKLAlpha-1-Acid-Glycoprotein, Antigen, Antiserum, Control1Product Code
- LKOAnti-Rnp Antibody, Antigen And Control2Product Code
- LKPAnti-Sm Antibody, Antigen And Control2Product Code
- LLLExtractable Antinuclear Antibody, Antigen And Control2Product Code
- LRMAnti-Dna Antibody (Enzyme-Labeled), Antigen, Control2Product Code
- LSWAnti-Dna Antibody, Antigen And Control2Product Code
- MGAAlpha-1 Microglobulin, Antigen, Antiserum, Control1Product Code
- MIDSystem, Test, Anticardiolipin Immunological2Product Code
- MLEEnzyme Immunoassay, Antiparietal Cell Antibody, Antigen, Control2Product Code
- MLHStrip, Hama Igg, Elisa, In Vitro Test System2Product Code
- MOBTest System, Antineutrophil Cytoplasmic Antibodies (Anca)2Product Code
- MQAAnti-Ribosomal P Antibodies2Product Code
- MSTAntibodies, Gliadin2Product Code
- MSVSystem,Test,Antibodies,B2 - Glycoprotein I (B2 - Gpi)2Product Code
- MVEBiosensor, Immunoassay, Myoglobin2Product Code
- MVJDevices, Measure, Antibodies To Glomerular Basement Membrane (Gbm)2Product Code
- MVMAutoantibodies, Endomysial(Tissue Transglutaminase)2Product Code
- NBOAutoantibodies, Skin (Desmoglein 1 And Desmoglein 3)2Product Code
- NBSAutoantibodies, Lkm-1 (Liver/Kidney Microsome, Type 1)2Product Code
- NBTAntibodies, Saccharomyces Cerevisiae (S.Cerevisiae)2Product Code
- NHXAntibodies, Anti-Cyclic Citrullinated Peptide (Ccp)2Product Code
- NIYAutoantibodies, Anti-Soluble Liver Antigen (Sla), Autoimmune Hepatitis2Product Code
- NJFAntibodies, Anti-Actin, Anti-Smooth Muscle2Product Code
- NOETest, System, Immunoassay, Lipoprotein-Associated Phospholipase A22Product Code
- NPHAntigen, Cartilage Oligomeric Matrix Protein (Comp)2Product Code
- NQDCardiac C-Reactive Protein, Antigen, Antiserum, And Control2Product Code
- NRIAutoantibodies, Nuclear Pore Glycoprotein Gp2102Product Code
- NRXComplement 4d (C4d) And Complement Receptor 1 (Cr1)2Product Code
- NSTAutoantibodies, Acetylcholine Receptor, Acetylcholine Blocking And Non-Blocking2Product Code
- NUMAutoantibodies, Nuclear Body Protein, Sp1002Product Code
- NWGAutoantibodies, Glutamic Acid Decarboxylase (Gad)2Product Code
- NXOCalprotectin, Fecal2Product Code
- NYOAutoantibodies, Anti-Ribonucleic Acid Polymerase (Rnap) Iii Antibody2Product Code
- OBEAnti-Ss-A 52 Autoantibodies2Product Code
- OBZAlpha-1-Antitrypsin Kit, Qualitative Phenotype2Product Code
- OCNInsulin Autoantibody Kit2Product Code
- OEGAutoantibodies, Skin (Bullous Pemphigoid 180 And Bullous Pemphigoid 2302Product Code
- OIFTyrosine Phosphatase (Ia-2) Autoantibody Assay2Product Code
- OKMAntibodies, Outer-Membrane Proteins2Product Code
- OPNAuto-Antibodies; Phosphatidylserine, Prothrombin, Phosphatidylserine/Prothrombin Complex2Product Code
- OPXImmunoglobulin A Kappa Heavy & Light Chain Combined2Product Code
- OPYIgal Heavy & Light Chain Combined2Product Code
- OQZAnti-Mutated Citrullinated Vimentin Igg2Product Code
- OSKAnti-Glutamate Receptor (Type Nmda) Ifa2Product Code
- OYLTryptase Assay System2Product Code
- OYVInherited Nucleotide Repeat Disorder Dna Test2Product Code
- PAFVoltage Gated Calcium Channel (Vgcc) Antibody Assay2Product Code
- PCG21-Hydroxylase Antibody (21-Ohab)2Product Code
- PCNImmunoglobulin G Kappa Heavy And Light Chain Combined2Product Code
- PCOImmunoglobulin G Lambda Heavy And Light Chain Combined2Product Code
- PDEImmunoglobulin M Kappa Heavy And Light Chain Combined2Product Code
- PDFImmunoglobulin M Lambda Heavy And Light Chain Combined2Product Code
- PETAnti-Ss-A Ro60 Autoantibodies2Product Code
- PHFZinc Transporter 8 Auto-Antibody2Product Code
- PJISevere Combined Immunodeficiency Disorder (Scid) Newborn Screening Test System2Product Code
- PNIAquaporin-4 Autoantibody2Product Code
- PTAGenetic Variant Detection And Health Risk Assessment System2Product Code
- PUWSystem, Test, Radioallergosorbent (Rast) Immunological, Exempt Allergens2Product Code
- PZHSerpina1 Variant Detection System2Product Code
- QATBrain Trauma Assessment Test2Product Code
- NZBQuality Control Material, Genetics, Dna2Product Code
- PGVAnti-Phospholipase A2 Receptor2Product Code
- QUKHuman Leukocyte Antigen (Hla) Typing Companion Diagnostic Test2Product Code
- SGGMass Spectrometric, Immunoglobulins (G, A, M, D, E)2Product Code
- Subpart G—Tumor Associated Antigen immunological Test SystemsCFR Sub-Part
- MicrobiologyReview Panel
- 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
VITEK IMMUNODIAGNOSTIC ASSAY SYSTEM (VIDAS)
- Page Type
- Cleared 510(K)
- PDF* The FDA doesn't provide PDFs for all submissions.
- Analyzed PDF
- 510(k) Number
- K891385
- 510(k) Type
- Traditional
- Applicant
- VITEK SYSTEMS, INC.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 4/18/1989
- Days to Decision
- 40 days