No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
---|---|---|---|---|---|---|---|---|
1 | 00884999002180 | 02J27-095 | 02J27-095 | UroVysion Bladder Cancer Kit | NSD | Test, fluorescence in situ hybridization (fish), for bladder cancer detection an Test, fluorescence in situ hybridization (fish), for bladder cancer detection and monitoring for recurrence | 3 | UroVysion |
2 | 00884999002142 | 02J27-025 | 02J27-025 | UroVysion Bladder Cancer Kit | NSD | Test, fluorescence in situ hybridization (fish), for bladder cancer detection an Test, fluorescence in situ hybridization (fish), for bladder cancer detection and monitoring for recurrence | 3 | UroVysion |
3 | 00884999002128 | 02J27-011 | 02J27-011 | ProbeChek UroVysion Bladder Cancer Kit Control Slides | OYU | Dna-probe kit, human chromosome | 2 | UroVysion |
4 | 00884999031357 | 8L49-030 | 8L49-30 | DNA Amp Check | PPM | General purpose reagent | 1 | Abbott |
5 | 00884999039278 | 4J94-23 | 4J94-23 | ViroSeq HIV-1 Genotyping Software v3.0 & Algorithm Advisor | NHS | Assay, genotype, hiv drug resistance, in vitro | 2 | ViroSeq |
6 | 00884999007475 | 4J94-93 | 4J94-93 | ViroSeq HIV-1 Genotyping System v2.0 | NHS | Assay, genotype, hiv drug resistance, in vitro | 2 | ViroSeq |
7 | 00884999007468 | 4J94-92 | 4J94-92 | Sequencing Consumables Kit | PPM | General purpose reagent | 1 | ViroSeq |
8 | 00884999007420 | 4J94-73 | 4J94-73 | PCR Cleanup Kit | PPM | General purpose reagent | 1 | ViroSeq |
9 | 00884999049130 | 09N77-055 | 09N77-055 | Abbott Universal Collection Kit | QJR | Reagents, 2019-novel coronavirus nucleic acid | RealTime | |
10 | 00884999049109 | 09N77-095 | 09N77-095 | Abbott RealTime SARS-CoV-2 Amplification Reagent Kit | QJR | Reagents, 2019-novel coronavirus nucleic acid | RealTime | |
11 | 00884999049086 | 09N77-085 | 09N77-085 | Abbott RealTime SARS-CoV-2 Control Kit | QJR | Reagents, 2019-novel coronavirus nucleic acid | RealTime | |
12 | 00884999049055 | 09N77-010 | 09N77-010 | Abbott RealTime SARS-CoV-2 Application CD-ROM | QJR | Reagents, 2019-novel coronavirus nucleic acid | RealTime | |
13 | 00884999048478 | 02J11-057 | 02J11-057 | VP 2000 System Software v2.1 with Protocols USB | KEY | STAINER, TISSUE, AUTOMATED | 1 | VP2000 |
14 | 00884999048065 | 06L83-008 | 06L83-008 | Abbott RealTime HIV-1 m2000 System Combined Application CD-ROM | MZF | Test, HIV detection | 2 | RealTime |
15 | 00884999047792 | 08N90-006 | 08N90-006 | Abbott RealTime IDH1m2000rt Application CD-ROM | OWD | Somatic gene mutation detection system | 3 | RealTime |
16 | 00884999047358 | 08N90-090 | 08N90-090 | Abbott RealTime IDH1 Amplification Reagent Kit | OWD | Somatic gene mutation detection system | 3 | RealTime |
17 | 00884999047341 | 08N90-080 | 08N90-080 | Abbott RealTime IDH1 Control Kit | OWD | Somatic gene mutation detection system | 3 | RealTime |
18 | 00884999047310 | 02J11-065 | 02J11-065 | VIP 2000 Upgrade Kit | KEY | STAINER, TISSUE, AUTOMATED | 1 | VP2000 |
19 | 00884999047297 | 09N21-002 | 09N21-002 | Abbott RealTime CMV m2000 System Combined Application CD-ROM | PAB | Cytomegalovirus (cmv) dna quantitative assay | 3 | RealTime |
20 | 00884999047051 | 08N82-080 | Abbott RealTime IDH2 Control Kit | OWD | Somatic gene mutation detection system | 3 | RealTime | |
21 | 00884999047044 | 08N82-090 | 08N82-090 | Abbott RealTime IDH2 Amplification Reagent Kit | OWD | Somatic gene mutation detection system | 3 | RealTime |
22 | 00884999047037 | 08N82-001 | 08N82-001 | Abbott RealTime IDH2 m2000rt Application CD-ROM | OWD | Somatic gene mutation detection system | 3 | RealTime |
23 | 00884999046603 | 03L78-061 | 03L78-061 | Abbott Proteinase K Recombinant, PCR Grade | PAB | Cytomegalovirus (cmv) dna quantitative assay | 3 | RealTime |
24 | 00884999046528 | 9K12-04 | 9K12-04 | multi-Collect Specimen Collection Kit | LSL,LIO,MKZ | DNA-REAGENTS, NEISSERIA,DEVICE, SPECIMEN COLLECTION,DNA PROBE, NUCLEIC ACID AMPL DNA-REAGENTS, NEISSERIA,DEVICE, SPECIMEN COLLECTION,DNA PROBE, NUCLEIC ACID AMPLIFICATION, CHLAMYDIA | Multi-Collect | |
25 | 00884999046511 | 9K12-03 | 9K12-03 | multi-Collect Specimen Collection Specimen Collection Kit | MKZ,LIO,LSL | DNA PROBE, NUCLEIC ACID AMPLIFICATION, CHLAMYDIA,DEVICE, SPECIMEN COLLECTION,DNA DNA PROBE, NUCLEIC ACID AMPLIFICATION, CHLAMYDIA,DEVICE, SPECIMEN COLLECTION,DNA-REAGENTS, NEISSERIA | Multi-Collect | |
26 | 00884999046153 | 02J11-042 | 02J11-042 | VIP 2000 Upgrade 250 mL Basin Kit | KEY | STAINER, TISSUE, AUTOMATED | 1 | VP2000 |
27 | 00884999046146 | 02J11-041 | 02J11-041 | VIP 2000 Upgrade 150 mL Basin Kit | KEY | STAINER, TISSUE, AUTOMATED | 1 | VP2000 |
28 | 00884999046122 | 02J11-063 | 02J11-063 | VP 2000 Processor, 100V | KEY | STAINER, TISSUE, AUTOMATED | 1 | VP2000 |
29 | 00884999046115 | 02J11-062 | 02J11-062 | VP 2000 Processor, 117V | KEY | STAINER, TISSUE, AUTOMATED | 1 | VP2000 |
30 | 00884999046108 | 02J11-061 | 02J11-061 | VP 2000 Processor, 230V | KEY | STAINER, TISSUE, AUTOMATED | 1 | VP2000 |
31 | 00884999045798 | 09N21-090 | 09N21-090 | Abbott RealTime CMV Amplification Reagent Kit | PAB | Cytomegalovirus (cmv) dna quantitative assay | 3 | RealTime |
32 | 00884999045781 | 09N21-080 | 09N21-080 | Abbott RealTime CMV Control Kit | PAB | Cytomegalovirus (cmv) dna quantitative assay | 3 | RealTime |
33 | 00884999045774 | 09N21-070 | 09N21-070 | Abbott RealTime CMV Calibrator Kit | PAB | Cytomegalovirus (cmv) dna quantitative assay | 3 | RealTime |
34 | 00884999042704 | 06L83-007 | 06L83-007 | Abbott RealTime HIV-1 m2000 System Combined Application CD-ROM | MZF | Test, hiv detection | 2 | RealTime |
35 | 00884999042681 | 04N45-004 | 04N45-004 | Abbott RealTime HCV m2000 System Combined Application CD-ROM | MZP | ASSAY,HYBRIDIZATION AND/OR NUCLEIC ACID AMPLIFICATION FOR DETECTION OF HEPATITIS ASSAY,HYBRIDIZATION AND/OR NUCLEIC ACID AMPLIFICATION FOR DETECTION OF HEPATITIS C RNA,HEPATITIS C VIRUS | 2 | RealTime |
36 | 00884999042667 | 02N43-004 | 02N43-004 | Abbott RealTime HBV m2000 System Combined Application CD-ROM | MKT | Hepatitis Viral B DNA Detection | 3 | RealTime |
37 | 00884999042513 | 08L21-002 | 08L21-002 | Abbott RealTime HCV Genotype II m2000 System Combined Application CD-ROM | OBF | Assay, genotyping, hepatitis c virus | 2 | RealTime |
38 | 00884999038462 | 2N40-91 | 2N40-91 | Abbott RealTime HBV Amplification Reagent Kit | MKT | Hepatitis Viral B DNA Detection | 3 | RealTime |
39 | 00884999038189 | 08N16-001 | 08N16-001 | VP 2000 Pretreatment Kit | OWE | Fluorescence in situ hybridization, anaplastic lymphoma kinase, gene rearrangement | 3 | VP2000 |
40 | 00884999037762 | 2N43-03 | 2N43-03 | Abbott RealTime HBV m2000 System Combined Application CD-ROM, Version 3.0 | MKT | Hepatitis Viral B DNA Detection | 3 | RealTime |
41 | 00884999037656 | 4N45-03 | 4N45-03 | Abbott RealTime HCV m2000 System Combined Application CD-ROM, Version 3.0 | MZP | ASSAY,HYBRIDIZATION AND/OR NUCLEIC ACID AMPLIFICATION FOR DETECTION OF HEPATITIS ASSAY,HYBRIDIZATION AND/OR NUCLEIC ACID AMPLIFICATION FOR DETECTION OF HEPATITIS C RNA,HEPATITIS C VIRUS | 2 | RealTime |
42 | 00884999037595 | 03N27-51 | 03N27-51 | Abbott VP2000 Processor Operations Manual, Rev. D | KEY | STAINER, TISSUE, AUTOMATED | 1 | VP2000 |
43 | 00884999037472 | 06L87-02 | 06L87-02 | Uracil-N-Glycosylase (UNG) | MZP,LSL,OBF,MZF,MKZ | ASSAY,HYBRIDIZATION AND/OR NUCLEIC ACID AMPLIFICATION FOR DETECTION OF HEPATITIS ASSAY,HYBRIDIZATION AND/OR NUCLEIC ACID AMPLIFICATION FOR DETECTION OF HEPATITIS C RNA,HEPATITIS C VIRUS,DNA-REAGENTS, NEISSERIA,Assay, genotyping, hepatitis c virus,Test, hiv detection,DNA PROBE, NUCLEIC ACID AMPLIFICATION, CHLAMYDIA | 1 | RealTime |
44 | 00884999037434 | 1N30-67 | 1N30-67 | Abbott RealTime HCV Including Uracil-N-Glycosylase (UNG) | MZP | ASSAY,HYBRIDIZATION AND/OR NUCLEIC ACID AMPLIFICATION FOR DETECTION OF HEPATITIS ASSAY,HYBRIDIZATION AND/OR NUCLEIC ACID AMPLIFICATION FOR DETECTION OF HEPATITIS C RNA,HEPATITIS C VIRUS | 2 | RealTime |
45 | 00884999037427 | 6L18-67 | 6L18-67 | Abbott RealTime HIV-1 Amplification Extended Use Including Uracil-N-Glycosylase (UNG) | MZF | Test, hiv detection | 2 | RealTime |
46 | 00884999037410 | 8L07-67 | 8L07-67 | Abbott RealTime CT/NG Amplification Reagent Extended Use Including Uracil-N-Glyc Abbott RealTime CT/NG Amplification Reagent Extended Use Including Uracil-N-Glycosylase (UNG) | LIO,MKZ,LSL | DEVICE, SPECIMEN COLLECTION,DNA PROBE, NUCLEIC ACID AMPLIFICATION, CHLAMYDIA,DNA DEVICE, SPECIMEN COLLECTION,DNA PROBE, NUCLEIC ACID AMPLIFICATION, CHLAMYDIA,DNA-REAGENTS, NEISSERIA | 1 | RealTime |
47 | 00884999037304 | 6L18-50 | 6L18-50 | Abbott RealTime HIV-1 Amplification Reagent Extended Use | MZF | Test, hiv detection | 2 | RealTime |
48 | 00884999037298 | 8L07-50 | 8L07-50 | Abbott RealTime CT/NG Amplification Reagent Extended Use with Pierceable Caps | LSL,LIO,MKZ | DNA-REAGENTS, NEISSERIA,DEVICE, SPECIMEN COLLECTION,DNA PROBE, NUCLEIC ACID AMPL DNA-REAGENTS, NEISSERIA,DEVICE, SPECIMEN COLLECTION,DNA PROBE, NUCLEIC ACID AMPLIFICATION, CHLAMYDIA | 1 | RealTime |
49 | 00884999037168 | 6L83-06 | 6L83-06 | Abbott RealTime HIV-1 m2000 System Combined Application CD-ROM, Version 6.0 | MZF | Test, hiv detection | 2 | RealTime |
50 | 00884999037113 | 06L98-05 | 06L98-05 | Abbott m2000 System Chlamydia trachomatis and Neisseria gonorrhoeae Application Abbott m2000 System Chlamydia trachomatis and Neisseria gonorrhoeae Application CD-ROM, Version 5.0 | LSL,LIO,MKZ | DNA-REAGENTS, NEISSERIA,DEVICE, SPECIMEN COLLECTION,DNA PROBE, NUCLEIC ACID AMPL DNA-REAGENTS, NEISSERIA,DEVICE, SPECIMEN COLLECTION,DNA PROBE, NUCLEIC ACID AMPLIFICATION, CHLAMYDIA | 1 | RealTime |
No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
---|---|---|---|---|---|---|
1 | 00608337103403 | 1001-0340 | OraQuick In Home HIV Test | ORASURE TECHNOLOGIES, INC. | ||
2 | 00608337001334 | 1001-0528 | OraQuick In Home HIV Test, Pharmacy | ORASURE TECHNOLOGIES, INC. | ||
3 | 00608337000962 | 1001-0374 | OraQuick In Home HIV Test (Not for Resale) | ORASURE TECHNOLOGIES, INC. | ||
4 | 00607158000083 | 65-9502-0 | The DPP® HIV-Syphilis is a single-use rapid, qualitative, multiplex, immunoassay The DPP® HIV-Syphilis is a single-use rapid, qualitative, multiplex, immunoassay for the detection of antibodies to Human Immunodeficiency Virus Types 1 and 2 (HIV-1/2), and/or Treponema pallidum bacteria (the causative agent of syphilis) in fingerstick whole blood, potassium-EDTA venous whole blood or potassium-EDTA plasma specimens. The test is intended to be used with the DPP Micro Reader. The test is intended for use by trained professionals in point of care and laboratory settings to aid in the diagnosis of HIV and syphilis infection. | DPP HIV-Syphilis | CHEMBIO DIAGNOSTIC SYSTEMS INC. | |
5 | 00607158000076 | 60-9549-0 | The Chembio HIV Reactive/Nonreactive Controls are quality control reagents for u The Chembio HIV Reactive/Nonreactive Controls are quality control reagents for use with the Chembio HIV 1/2 STAT-PAK® Assay only. Chembio HIV Reactive/Nonreactive Controls are human, plasma-based reagents. The Controls are specifically formulated and manufactured to ensure performance of the test, and are used to verify the user’s ability to properly perform the test and interpret the results. Each HIV Rapid Test Control Pack contains a Product Insert and three Vials (one HIV 1 Reactive Control, one HIV 2 Reactive Control and one Nonreactive Control).One Vial containing 0.25 mL of heat inactivated human plasma positive for antibodies to HIV-1, diluted in normal human plasma. Negative for Hepatitis B surface antigen, Hepatitis C antibody and HTLV I/II antibodies.One Vial containing 0.25 mL of heat inactivated human plasma positive for antibodies to HIV-2, diluted in normal human plasma. Negative for Hepatitis B surface antigen, Hepatitis C antibody and HTLV I/II antibodies.One Vial containing 0.25 mL of normal human plasma negative for antibodies to HIV-1 and HIV-2. Negative for Hepatitis B surface antigen, Hepatitis C antibody and HTLV I/II antibodies. | Chembio HIV Reactive/Nonreactive Controls | CHEMBIO DIAGNOSTIC SYSTEMS INC. | |
6 | 00607158000069 | 60-9507-0 | The Chembio SURE CHECK® HIV 1/2 Assay is a single-use immunochromatographic test The Chembio SURE CHECK® HIV 1/2 Assay is a single-use immunochromatographic test for the detection of antibodies to Human Immunodeficiency Virus Types 1 (HIV-1) and Type 2 (HIV-2) in fingerstick whole blood, venous whole blood, and serum or plasma specimens. The Chembio SURE CHECK® HIV 1/2 Assay is intended for use as a point-of-care test to aid in the diagnosis of infection with HIV-1 and HIV-2. This test is suitable for use in multi-test algorithms designed for the statistical validation of rapid HIV test results. When multiple rapid HIV tests are available, this test should be used in appropriate multi-test algorithms. Each kit contains 25 individually pouched tests each containing 1 Sampler with a Test Strip inside, 1 Buffer Vial attached to the Sampler (~350μL), 1 Sterile Safety Lancet, 1 Bandage, 1 Desiccant Packet; 25 Disposable Test Stands; 1 Product Insert; 25 Copies of Subject Information Notice. | Chembio SURE CHECK HIV 1/2 Assay | CHEMBIO DIAGNOSTIC SYSTEMS INC. | |
7 | 00607158000052 | 60-9505-1 | The Chembio HIV 1/2 STAT-PAK® Assay is a single-use immunochromatographic test f The Chembio HIV 1/2 STAT-PAK® Assay is a single-use immunochromatographic test for the detection of antibodies to Human Immunodeficiency Virus Type 1 (HIV-1) and Type 2 (HIV-2) in fingerstick whole blood, venous whole blood, serum or plasma specimens. The Chembio HIV 1/2 STAT-PAK® assay is intended for use as a point-of-care test to aid in the diagnosis of infection with HIV-1 and HIV-2. This test is suitable for use in multi-test algorithms designed for the statistical validation of rapid HIV test results. When multiple rapid HIV tests are available, this test should be used in appropriate multi-test algorithms. Each kit contains 20 individually pouched tests, 1 bottle of HIV Running Buffer, 20 Disposable Loops, 1 Product Insert, and 20 Copies of Subject Information Notice. | Chembio HIV 1/2 Stat-Pak Assay | CHEMBIO DIAGNOSTIC SYSTEMS INC. | |
8 | 00607158000045 | 60-9552-0 | The Chembio HIV Reactive/Nonreactive Controls are quality control reagents for u The Chembio HIV Reactive/Nonreactive Controls are quality control reagents for use with the Chembio DPP HIV 1/2 Assay only. Chembio HIV Reactive/Nonreactive Controls are human, plasma-based reagents. The Controls are specifically formulated and manufactured to ensure performance of the test, and are used to verify the user’s ability to properly perform the test and interpret the results. Each HIV Rapid Test Control Pack contains a Product Insert and three Vials (one HIV 1 Reactive Control, one HIV 2 Reactive Control and one Nonreactive Control) as described. One Vial containing 0.5mL of heat inactivated human plasma positive for antibodies to HIV-1, diluted in normal human plasma. Negative for Hepatitis B surface antigen, Hepatitis C antibody and HTLV I/II antibodies.One Vial containing 0.5mL of heat inactivated human plasma positive for antibodies to HIV-2, diluted in normal human plasma. Negative for Hepatitis B surface antigen, Hepatitis C antibody and HTLV I/II antibodies. One Vial containing 0.5mL of normal human plasma negative for antibodies to HIV-1 and HIV-2. Negative for Hepatitis B surface antigen, Hepatitis C antibody and HTLV I/II antibodies. | Chembio DPP HIV 1/2 Rapid Test Control Pack | CHEMBIO DIAGNOSTIC SYSTEMS INC. | |
9 | 00607158000038 | 60-9546-0 | The Clearview® HIV Reactive/Nonreactive Controls are quality control reagents fo The Clearview® HIV Reactive/Nonreactive Controls are quality control reagents for use with the Clearview® COMPLETE HIV 1/2 Assay only. Clearview® HIV Reactive/Nonreactive Controls are human, plasma-based reagents. The Controls are specifically formulated and manufactured to ensure performance of the test, and are used to verify the user’s ability to properly perform the test and interpret the results. Each HIV Rapid Test Control Pack contains a Product Insert and three Vials (one HIV 1 Reactive Control, one HIV 2 Reactive Control and one Nonreactive Control).One Vial containing 0.25 mL of heat inactivated human plasma positive for antibodies to HIV-1, diluted in normal human plasma. Negative for Hepatitis B surface antigen, Hepatitis C antibody and HTLV I/II antibodies.One Vial containing 0.25 mL of heat inactivated human plasma positive for antibodies to HIV-2, diluted in normal human plasma. Negative for Hepatitis B surface antigen, Hepatitis C antibody and HTLV I/II antibodies.One Vial containing 0.25 mL of normal human plasma negative for antibodies to HIV-1 and HIV-2. Negative for Hepatitis B surface antigen, Hepatitis C antibody and HTLV I/II antibodies. | Clearview HIV Reactive/Nonreactive Controls | CHEMBIO DIAGNOSTIC SYSTEMS INC. | |
10 | 00607158000021 | 60-9523-0 | The Clearview® COMPLETE HIV 1/2 assay is a single-use immunochromatographic test The Clearview® COMPLETE HIV 1/2 assay is a single-use immunochromatographic test for the detection of antibodies to Human Immunodeficiency Virus Types 1 (HIV-1) and Type 2 (HIV-2) in fingerstick whole blood, venous whole blood, and serum or plasma specimens. The Clearview® COMPLETE HIV 1/2 assay is intended for use as a point-of-care test to aid in the diagnosis of infection with HIV-1 and HIV-2. This test is suitable for use in multi-test algorithms designed for the statistical validation of rapid HIV test results. When multiple rapid HIV tests are available, this test should be used in appropriate multi-test algorithms. Each kit contains 25 individually pouched tests, 25 Disposable Test Stands, 1 Product Insert, and 25 Copies of Subject Information Notice. | Clearview Complete HIV 1/2 | CHEMBIO DIAGNOSTIC SYSTEMS INC. | |
11 | 00607158000007 | 65-9500-0 | The Chembio DPP® HIV 1/2 Assay is a single-use immunochromatographic test for th The Chembio DPP® HIV 1/2 Assay is a single-use immunochromatographic test for the detection of antibodies to Human Immunodeficiency Virus Types 1 and 2 (HIV-1/2) in oral fluid, fingerstick whole blood, venous whole blood, serum, or plasma samples. The Chembio DPP HIV 1/2 Assay is intended for use as a point-of-care test to aid in the diagnosis of infection with HIV-1 and HIV-2. This test is suitable for use in multi-test algorithms designed for the statistical validation of rapid HIV test results. When multiple rapid HIV tests are available, this test should be used in appropriate multi-test algorithms. Each kit contains 20 individually pouched tests, 1 bottle of DPP HIV Running Buffer, 20 Sampletainer Bottles, 20 Oral Fluid Swabs, 20 Disposable Loops, 1 Product Insert, and 20 Copies of Subject Information Notice. | Chembio DPP HIV 1/2 Assay | CHEMBIO DIAGNOSTIC SYSTEMS INC. | |
12 | 00380740146252 | 08P0702 | 08P0702 | Alinity i HIV Ag/Ab Combo Calibrator | Alinity | ABBOTT GMBH |
13 | 00380740136574 | 08P0712 | 08P0712 | Alinity i HIV Ag/Ab Combo Controls | Alinity | ABBOTT GMBH |
14 | 00380740121778 | 08P0731 | 08P0731 | Alinity i HIV Ag/Ab Combo Reagent Kit 1200 Tests | Alinity | ABBOTT GMBH |
15 | 00380740121754 | 08P0721 | 08P0721 | Alinity i HIV Ag/Ab Combo Reagent Kit 200 Tests | Alinity | ABBOTT GMBH |
16 | 00380740003906 | 2P36-35 | 02P3635 | ARCHITECT HIV Ag/Ab Combo Reagent Kit | ARCHITECT | ABBOTT GMBH |
17 | 00380740003890 | 2P36-25 | 02P3625 | ARCHITECT HIV Ag/Ab Combo Reagent Kit | ARCHITECT | ABBOTT GMBH |
18 | 00380740003883 | 2P36-10 | 02P3610 | ARCHITECT HIV Ag/Ab Combo Controls | ARCHITECT | ABBOTT GMBH |
19 | 00380740003876 | 2P36-01 | 02P3601 | ARCHITECT HIV Ag/Ab Combo Calibrator | ARCHITECT | ABBOTT GMBH |
20 | 15420045504240 | SPECIMEN DIL, VIRAL ASSAY, APTIMA, IVD | PRD-03503 | N/A | APTIMA | HOLOGIC, INC. |
21 | 15420045504233 | HIV VIRAL ASSAY, CNTRLS, APTIMA, US IVD | PRD-03567 | N/A | APTIMA | HOLOGIC, INC. |
22 | 15420045504226 | HIV VIRAL ASSAY CAL, APTIMA, US IVD | PRD-03566 | APTIMA | HOLOGIC, INC. | |
23 | 15420045504219 | HIV VIRAL ASSAY, APTIMA, 100T, US IVD | PRD-03565 | APTIMA | HOLOGIC, INC. | |
24 | 10758750031597 | 6842782 | 6842782 | VITROS Immunodiagnostic Products HIV Combo Calibrator | VITROS | ORTHO CLINICAL DIAGNOSTICS |
25 | 10758750031580 | 6842781 | 6842781 | VITROS Immunodiagnostic Products HIV Combo Reagent Pack | VITROS | ORTHO CLINICAL DIAGNOSTICS |
26 | 10758750001538 | 6801862 | 6801862 | VITROS Immunodiagnostic Products Anti-HIV 1+2 Calibrator | VITROS | ORTHO CLINICAL DIAGNOSTICS |
27 | 10758750001521 | 6801861 | 6801861 | VITROS Immunodiagnostic Products Anti-HIV 1+2 Reagent Pack | VITROS | ORTHO CLINICAL DIAGNOSTICS |
28 | 10628451188152 | 815311007514 | HIV-1 Antibody Test Controls (Test Controls) are external quality control agents HIV-1 Antibody Test Controls (Test Controls) are external quality control agents intended for use only with Reveal G4. | HIV-1 Antibody Test Controls | MEDMIRA LABORATORIES INC | |
29 | 10628451188145 | 815311007521 | HIV-1 Antibody Test Controls (Test Controls) are external quality control agents HIV-1 Antibody Test Controls (Test Controls) are external quality control agents intended for use only with Reveal G4. | HIV-1 Antibody Test Controls | MEDMIRA LABORATORIES INC | |
30 | 10628451188138 | 815311007538 | Reveal G4 Rapid HIV-1 Antibody Test (Reveal G4) is a single use, qualitatitve im Reveal G4 Rapid HIV-1 Antibody Test (Reveal G4) is a single use, qualitatitve immunoassay to detect antibodies to Human Immunodeficiency Virus Type 1 (HIV-1) in human whole blood (venipuncture and fingerstick), serum, and plasma. Reveal G4 is intended for use as a point-of-care test to aid in the diagnosis of infection with HIV-1. This test is suitable for use in multi-test algorithms designed for statistical validation of rapid HIV test results. When multiple rapid tests are available, this test should be used in appropriate multi-test algorithms. | Reveal G4 Rapid HIV-1 Antibody Test | MEDMIRA LABORATORIES INC | |
31 | 10628451188121 | 815311007569 | Reveal G4 Rapid HIV-1 Antibody Test (Reveal G4) is a single use, qualitatitve im Reveal G4 Rapid HIV-1 Antibody Test (Reveal G4) is a single use, qualitatitve immunoassay to detect antibodies to Human Immunodeficiency Virus Type 1 (HIV-1) in human whole blood (venipuncture and fingerstick), serum, and plasma. Reveal G4 is intended for use as a point-of-care test to aid in the diagnosis of infection with HIV-1. This test is suitable for use in multi-test algorithms designed for statistical validation of rapid HIV test results. When multiple rapid tests are available, this test should be used in appropriate multi-test algorithms. | Reveal G4 Rapid HIV-1 Antibody Test | MEDMIRA LABORATORIES INC | |
32 | 10628451188114 | 815311007552 | Reveal G4 Rapid HIV-1 Antibody Test (Reveal G4) is a single use, qualitatitve im Reveal G4 Rapid HIV-1 Antibody Test (Reveal G4) is a single use, qualitatitve immunoassay to detect antibodies to Human Immunodeficiency Virus Type 1 (HIV-1) in human whole blood (venipuncture and fingerstick), serum, and plasma. Reveal G4 is intended for use as a point-of-care test to aid in the diagnosis of infection with HIV-1. This test is suitable for use in multi-test algorithms designed for statistical validation of rapid HIV test results. When multiple rapid tests are available, this test should be used in appropriate multi-test algorithms. | Reveal G4 Rapid HIV-1 Antibody Test | MEDMIRA LABORATORIES INC | |
33 | 10628451188107 | 815311007545 | HIV-1 Antibody Test Controls (Test Controls) are external quality control agents HIV-1 Antibody Test Controls (Test Controls) are external quality control agents intended for use only with Reveal G4. | HIV-1 Antibody Test Controls | MEDMIRA LABORATORIES INC | |
34 | 10628451188022 | 815311007569 | 815311007569 | Reveal G3 Rapid HIV-1 Antibody Test is a single use, qualitative immunoassay to Reveal G3 Rapid HIV-1 Antibody Test is a single use, qualitative immunoassay to detect antibodies to Human Immunodeficiency Virus Type 1 (HIV-1) in human serum or plasma. The Reveal G3 Rapid HIV-1 Antibody Test is intended for use as a point-of-care test to aid in diagnosis of infection with HIV-1. This test is suitable for use in multi-test algorithms designed for statistical validation of rapid HIV test results. When multiple rapid tests are available, this test should be used in appropriate multi-test algorithms. | Reveal G3 Rapid HIV-1 Antibody Test | MEDMIRA LABORATORIES INC |
35 | 07613336215845 | 08836973160 | 08836973160 | Elecsys HIV Duo | Elecsys HIV Duo | ROCHE DIAGNOSTICS GMBH |
36 | 07613336170212 | 08924180160 | 08924180160 | Elecsys HIV combi PT | ROCHE DIAGNOSTICS GMBH | |
37 | 07613336170182 | 08924163160 | 08924163160 | Elecsys HIV combi PT | ROCHE DIAGNOSTICS GMBH | |
38 | 07613336166949 | 08836973190 | 08836973190 | Elecsys HIV Duo | ROCHE DIAGNOSTICS GMBH | |
39 | 06865979010313 | 90-1031 | 90-1031 | INSTI HIV-1/HIV-2 Control Test | INSTI HIV-1/HIV-2 Control Test | BIOLYTICAL LABORATORIES INC |
40 | 06865979010306 | 90-1030 | 90-1030 | HIV-1 Control Test Kit | HIV-1 Control Test Kit | BIOLYTICAL LABORATORIES INC |
41 | 06865979010207 | Without Support | 90-1020 | 24 tests without support material | INSTI HIV-1/HIV-2 Antibody Test | BIOLYTICAL LABORATORIES INC |
42 | 06865979010191 | Single | 90-1019 | Single-use rapid assay for the detection of antibodies to Human Immunodeficiency Single-use rapid assay for the detection of antibodies to Human Immunodeficiency Virus Type 1 and Type 2 (HIV-1, HIV-2) | INSTI HIV-1/HIV-2 Antibody Test | BIOLYTICAL LABORATORIES INC |
43 | 06865979010184 | With Support | 90-1018 | 24 Tests with support materials | INSTI HIV-1/HIV-2 Antibody Test | BIOLYTICAL LABORATORIES INC |
44 | 06865978010710 | 80-1071 | 80-1071 | INSTI Test Controls HIV-1 | INSTI Test Controls HIV-1 | BIOLYTICAL LABORATORIES INC |
45 | 06865978010376 | 80-1037 | 80-1037 | INSTI HIV-1/HIV-2 Test Controls | INSTI HIV-1/HIV-2 Test Controls | BIOLYTICAL LABORATORIES INC |
46 | 05391516746113 | 1206530 | 1206530 | Uni-Gold™ Recombigen® HIV Controls | Uni-Gold™ | TRINITY BIOTECH PUBLIC LIMITED COMPANY |
47 | 05391516746106 | 1206506 | 1206506 | Uni-Gold™ Recombigen® HIV-1/2 | Uni-Gold™ | TRINITY BIOTECH PUBLIC LIMITED COMPANY |
48 | 04015630942510 | 06924115160 | 06924115160 | PreciControl HIV; HIV-2 + GrpO | ROCHE DIAGNOSTICS GMBH | |
49 | 04015630942503 | 06924107160 | 06924107160 | PreciControl HIV Gen II | ROCHE DIAGNOSTICS GMBH | |
50 | 04015630942497 | 05390095160 | 05390095160 | HIV combi PT Elecsys cobas e 100 | Elecsys HIV combi PT | ROCHE DIAGNOSTICS GMBH |