Other products from "ROCHE MOLECULAR SYSTEMS, INC."
No Primary DI Version or Model Catalog Number Device Description Product Code Product Code Name Device Class Brand Name
1 00875197006254 08688214190 08688214190 QLX Nucleic acid amplification test for the quantitation of Epstein-Barr virus (EBV) DNA 2 cobas&#x00AE EBV/BKV Control Kit
2 00875197005998 07948352190 07948352190 NPR,NPQ TEST, FACTOR II G20210A MUTATIONS, GENOMIC DNA PCR,TEST, FACTOR V LEIDEN MUTATIO TEST, FACTOR II G20210A MUTATIONS, GENOMIC DNA PCR,TEST, FACTOR V LEIDEN MUTATIONS, GENOMIC DNA PCR 2 cobas Factor II and Factor V Test
3 00875197005646 07402678190 07402678190 PGX Groups A, C And G Beta-Hemolytic Streptococcus Nucleic Acid Amplification System 2 cobas® Strep A Quality Control Kit for use on the cobas® Liat® System
4 00875197005363 2.0 07102577190 OOI,LSL,MKZ real time Nucleic acid amplification system,DNA-REAGENTS, NEISSERIA,DNA PROBE, N real time Nucleic acid amplification system,DNA-REAGENTS, NEISSERIA,DNA PROBE, NUCLEIC ACID AMPLIFICATION, CHLAMYDIA 1 cobas® 4800 CT/NG Test v2.0
5 00875197005356 2.0 07102569190 LSL,MKZ,OOI DNA-REAGENTS, NEISSERIA,DNA PROBE, NUCLEIC ACID AMPLIFICATION, CHLAMYDIA,real ti DNA-REAGENTS, NEISSERIA,DNA PROBE, NUCLEIC ACID AMPLIFICATION, CHLAMYDIA,real time Nucleic acid amplification system 1 cobas® 4800 CT/NG Test v2.0
6 00875197004458 1.0 06768318190 OQO Herpes Simplex Virus Nucleic Acid Amplification Assay 2 cobas® 4800 Systems Internal Control Kit
7 00875197004427 1.0 06768172190 NQX,OOI SYSTEM, NUCLEIC ACID AMPLIFICATION TEST, DNA, METHICILLIN RESISTANT STAPHYLOCOCC SYSTEM, NUCLEIC ACID AMPLIFICATION TEST, DNA, METHICILLIN RESISTANT STAPHYLOCOCCUS AUREUS, DIRECT SPECIMEN,real time Nucleic acid amplification system 2 cobas® MRSA/SA Test
8 00875197004410 1.0 06768113190 OOI,NQX real time Nucleic acid amplification system,SYSTEM, NUCLEIC ACID AMPLIFICATION T real time Nucleic acid amplification system,SYSTEM, NUCLEIC ACID AMPLIFICATION TEST, DNA, METHICILLIN RESISTANT STAPHYLOCOCCUS AUREUS, DIRECT SPECIMEN 2 cobas® MRSA/SA Test
9 00875197004120 05985536190 05985536190 OWD Somatic gene mutation detection system 3 cobas® DNA Sample Preparation Kit
10 00875197003215 1.0 05235847190 LSL,OOI,MKZ DNA-REAGENTS, NEISSERIA,real time Nucleic acid amplification system,DNA PROBE, N DNA-REAGENTS, NEISSERIA,real time Nucleic acid amplification system,DNA PROBE, NUCLEIC ACID AMPLIFICATION, CHLAMYDIA 1 cobas® 4800 System Control Diluent Kit
11 00875197003185 05235804190 05235804190 MAQ KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS 3 cobas® 4800 System Sample Preparation Kit
12 00875197003178 05235782190 05235782190 MAQ KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS 3 cobas® 4800 System Sample Preparation Kit
13 00875197001983 03568555190 03568555190 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 COBAS® AmpliPrep/ COBAS® TaqMan® HCV Test
14 00875197001068 2 03302563018 COBAS® AmpliScreen HCV Test, v2.0
15 00875197000993 2 03155935018 MTL MONITOR,TEST,HIV-1 3 COBAS AMPLICOR HIV-1 Monitor Test, version 1.5
16 08430215046203 03531414001 03531414001 OOI real time Nucleic acid amplification system 2 LightCycler® 2.0 Instrument
17 07613336171295 08988218001 08988218001 JQW STATION, PIPETTING AND DILUTING, FOR CLINICAL USE 1 cobas&#x00AE prime Secondary Tube Tray
18 07613336146644 08106568001 08106568001 LXG EQUIPMENT, LABORATORY, GENERAL PURPOSE, LABELED OR PROMOTED FOR A SPECIFIC MEDICAL USE 1 AVENIO Millisect
19 04015630925537 03121453001 03121453001 JJF ANALYZER, CHEMISTRY, MICRO, FOR CLINICAL USE 1 COBAS® TaqMan®
20 00875197006421 09040897190 09040897190 PAB Cytomegalovirus (cmv) dna quantitative assay 3 cobas® CMV
21 00875197006131 08244049190 08244049190 cobas Babesia
22 00875197005776 07460066190 07460066190 MKZ,LSL,OOI DNA PROBE, NUCLEIC ACID AMPLIFICATION, CHLAMYDIA,DNA-REAGENTS, NEISSERIA,real ti DNA PROBE, NUCLEIC ACID AMPLIFICATION, CHLAMYDIA,DNA-REAGENTS, NEISSERIA,real time Nucleic acid amplification system 1 cobas CTNG Qualitative nucleic acid test for use on the cobas 6800/8800 Systems
23 00875197005752 07460155190 07460155190 MAQ Kit, Dna Detection, Human Papillomavirus 3 cobas HPV for use on the cobas 6800/8800 systems
24 00875197004939 07001037190 07001037190 PAB Cytomegalovirus (cmv) dna quantitative assay 3 cobas CMV Control Kit
25 00875197004045 2.0 05969484190 cobas® TaqScreen MPX Test, v2.0
26 00875197003260 05235898190 05235898190 MAQ KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS 3 cobas® 4800 HPV Amplification/Detection Kit
27 00875197003253 05235880190 05235880190 MAQ KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS 3 cobas® 4800 HPV Amplification/Detection Kit
28 00875197003024 2 05212308190 MZF Test, hiv detection 2 COBAS® AmpliPrep/ COBAS® TaqMan® HIV- 1 Test, version 2.0
29 00875197002676 05002125190 05002125190 cobas® TaqScreen Cadaveric Specimen Diluent Kit
30 00875197002218 04404220190 04404220190 cobas® TaqScreen Wash Reagent
31 00875197002003 03577163190 03577163190 MKT Hepatitis Viral B DNA Detection 3 COBAS® TaqMan® HBV Test, For Use With The High Pure System
32 00875197001099 2 03322114018 COBAS® AmpliScreen HIV-1 Test, v1.5
33 00875197000030 20759899123 20759899123 COBAS® AMPLICOR Wash Buffer
34 07613336193297 09341935001 09341935001 GWW Ataxiagraph 1 Floodlight MS Draw Shape Test
35 07613336193280 09341927001 09341927001 GWW Ataxiagraph 1 Floodlight MS Draw Shape Test
36 07613336193259 09341889001 09341889001 GWW Ataxiagraph 1 Floodlight MS Pinching Test
37 07613336119563 07886977001 07886977001 OOI real time Nucleic acid amplification system 2 cobas Liat Software Version 3.0
38 04038377020556 03502295001 03502295001 MKT Hepatitis Viral B DNA Detection 3 High Pure System Viral Nucleic Acid Kit
39 00875197006490 09040919190 09040919190 PAB Cytomegalovirus (cmv) dna quantitative assay 3 cobas® CMV Control Kit
40 00875197006483 09040536190 09040536190 MZF Test, HIV detection 2 cobas® HIV-1/HIV- 2 192T
41 00875197006445 09051554190 09051554190 MZF Test, HIV detection 2 cobas® NHP Negative Control Kit
42 00875197006261 08688206190 08688206190 QLX Nucleic acid amplification test for the quantitation of Epstein-Barr virus (EBV) DNA 2 cobas&#x00AE EBV
43 00875197005264 1.0 06768253190 OQO Herpes Simplex Virus Nucleic Acid Amplification Assay 2 cobas® 4800 System Lysis Kit
44 00875197004229 06471463190 06471463190 OWD Somatic gene mutation detection system 3 cobas® EGFR Mutation Test
45 00875197004182 2 05989060190 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 COBAS® TaqMan® HCV Test For Use With the High Pure System
46 00875197004137 05985579190 05985579190 OWD Somatic gene mutation detection system 3 cobas® 4800 BRAF V600 Mutation Test
47 00875197002102 03599779190 03599779190 COBAS® AmpliScreen HBV Test
48 00875197001051 03302555018 03302555018 COBAS® AmpliScreen Multiprep Specimen Preparation and Control Kit
49 07613336193273 09341919001 09341919001 PTY Computerized Cognitive Assessment Aid, Exempt 2 Floodlight MS Cognitive Test
50 07613336193266 09341897001 09341897001 PTY Computerized Cognitive Assessment Aid, Exempt 2 Floodlight MS Cognitive Test
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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
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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.
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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.
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