Other products from "ABBOTT MOLECULAR INC."
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 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
48 00884999037168 6L83-06 6L83-06 Abbott RealTime HIV-1 m2000 System Combined Application CD-ROM, Version 6.0 MZF Test, hiv detection 2 RealTime
49 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
50 00884999036444 08L21-66 08L21-66 Uracil-N-Glycosylase (UNG) for use in conjunction with Abbott RealTime HCV Genot Uracil-N-Glycosylase (UNG) for use in conjunction with Abbott RealTime HCV Genotype II Assay OBF Assay, genotyping, hepatitis c virus 2 RealTime
Other products with the same Product Code "MZF"
No Primary DI Version or Model Catalog Number Device Description Brand Name Organization Name
1 00686597010310 90-1031 90-1031 INSTI HIV-1/HIV-2 Control Test Kit INSTI HIV-1/HIV-2 Control Test Kit BIOLYTICAL LABORATORIES INC
2 00686597010303 90-1030 90-1030 INSTI HIV-1 Control Test Kit INSTI HIV-1 Control Test Kit BIOLYTICAL LABORATORIES INC
3 00686597010198 90-1019 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
4 00630414600390 10995459 10995459 CHIV - Atellica IM - RGT - 100T Atellica IM CHIV SIEMENS HEALTHCARE DIAGNOSTICS INC.
5 00630414599342 10995611 10995611 HIV 1/O/2 (eHIV) - Atellica IM - RGT - 200T Atellica IM EHIV SIEMENS HEALTHCARE DIAGNOSTICS INC.
6 00630414598550 10995528 10995528 CHIV QC Kit Atellica IM - CLT 5 x 1 x 15.0mL Atellica IM CHIV QC SIEMENS HEALTHCARE DIAGNOSTICS INC.
7 00630414590202 10697214 10697214 ADVIA Centaur® CHIV Quality Control Material ADVIA Centaur® CHIV QC SIEMENS HEALTHCARE DIAGNOSTICS INC.
8 00630414589749 10696880 10696880 ADVIA Centaur® CHIV assay (100 tests) ADVIA Centaur® CHIV SIEMENS HEALTHCARE DIAGNOSTICS INC.
9 00630414511245 10332613 1622429 HIV 1/O/2 Enhanced (EHIV) (1-pack) 200T Assay Kit ADVIA Centaur® EHIV SIEMENS HEALTHCARE DIAGNOSTICS INC.
10 00630414509372 10309010 1324827 HIV 1/O/2 Enhanced (EHIV) Quality Control Material Kit ADVIA Centaur® Systems EHIV QC SIEMENS HEALTHCARE DIAGNOSTICS INC.
11 00630414457611 10335367 127418B HIV RNA 3.0 Assay (bDNA) US IVD (Box 2) VERSANT® HIV-1 RNA 3.0 Assay bDNA SIEMENS HEALTHCARE DIAGNOSTICS INC.
12 00630414457604 10335480 127418A HIV RNA 3.0 Assay (bDNA) US IVD (Box 1) VERSANT® HIV-1 RNA 3.0 Assay bDNA SIEMENS HEALTHCARE DIAGNOSTICS INC.
13 00630414301280 11207266 11207266 CHIV - Atellica IM - RGT - 100T Atellica IM CHIV SIEMENS HEALTHCARE DIAGNOSTICS INC.
14 00628451188094 815311007606 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. Universal Buffer MEDMIRA LABORATORIES INC
15 00628451188087 815311007590 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
16 00628451188070 815311000591 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
17 00628451188063 815311007576 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
18 00628451188056 815311007583 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
19 00628451188049 1009785RDB-G3 1009785RDB-G3 The package contains replacement component for use only with Reveal G3 Rapid HIV The package contains replacement component for use only with Reveal G3 Rapid HIV-1 Antibody Test. The component is lot-specific. MedMira Universal Buffer MEDMIRA LABORATORIES INC
20 00628451188032 1009785RCP-G3 1009785RCP-G3 The package contains replacement component for use only with Reveal G3 Rapid HIV The package contains replacement component for use only with Reveal G3 Rapid HIV-1 Antibody Test. Components are lot-specific. MedMira Human HIV-1 Human Test Control MEDMIRA LABORATORIES INC
21 00628451188018 815311000591 815311000591 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
22 00608337103403 1001-0340 OraQuick In Home HIV Test ORASURE TECHNOLOGIES, INC.
23 00608337001334 1001-0528 OraQuick In Home HIV Test, Pharmacy ORASURE TECHNOLOGIES, INC.
24 00608337000962 1001-0374 OraQuick In Home HIV Test (Not for Resale) ORASURE TECHNOLOGIES, INC.
25 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.
26 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.
27 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.
28 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.
29 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.
30 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.
31 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.
32 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.
33 00380740146252 08P0702 08P0702 Alinity i HIV Ag/Ab Combo Calibrator Alinity ABBOTT GMBH
34 00380740136574 08P0712 08P0712 Alinity i HIV Ag/Ab Combo Controls Alinity ABBOTT GMBH
35 00380740121778 08P0731 08P0731 Alinity i HIV Ag/Ab Combo Reagent Kit 1200 Tests Alinity ABBOTT GMBH
36 00380740121754 08P0721 08P0721 Alinity i HIV Ag/Ab Combo Reagent Kit 200 Tests Alinity ABBOTT GMBH
37 00380740003906 2P36-35 02P3635 ARCHITECT HIV Ag/Ab Combo Reagent Kit ARCHITECT ABBOTT GMBH
38 00380740003890 2P36-25 02P3625 ARCHITECT HIV Ag/Ab Combo Reagent Kit ARCHITECT ABBOTT GMBH
39 00380740003883 2P36-10 02P3610 ARCHITECT HIV Ag/Ab Combo Controls ARCHITECT ABBOTT GMBH
40 00380740003876 2P36-01 02P3601 ARCHITECT HIV Ag/Ab Combo Calibrator ARCHITECT ABBOTT GMBH
41 15420045504240 SPECIMEN DIL, VIRAL ASSAY, APTIMA, IVD PRD-03503 N/A APTIMA HOLOGIC, INC.
42 15420045504233 HIV VIRAL ASSAY, CNTRLS, APTIMA, US IVD PRD-03567 N/A APTIMA HOLOGIC, INC.
43 15420045504226 HIV VIRAL ASSAY CAL, APTIMA, US IVD PRD-03566 APTIMA HOLOGIC, INC.
44 15420045504219 HIV VIRAL ASSAY, APTIMA, 100T, US IVD PRD-03565 APTIMA HOLOGIC, INC.
45 10758750031597 6842782 6842782 VITROS Immunodiagnostic Products HIV Combo Calibrator VITROS ORTHO CLINICAL DIAGNOSTICS
46 10758750031580 6842781 6842781 VITROS Immunodiagnostic Products HIV Combo Reagent Pack VITROS ORTHO CLINICAL DIAGNOSTICS
47 10758750001538 6801862 6801862 VITROS Immunodiagnostic Products Anti-HIV 1+2 Calibrator VITROS ORTHO CLINICAL DIAGNOSTICS
48 10758750001521 6801861 6801861 VITROS Immunodiagnostic Products Anti-HIV 1+2 Reagent Pack VITROS ORTHO CLINICAL DIAGNOSTICS
49 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
50 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