Other products from "SIEMENS HEALTHCARE DIAGNOSTICS INC."
No Primary DI Version or Model Catalog Number Device Description Product Code Product Code Name Device Class Brand Name
1 00842768039010 10642445 DF150 Alkaline Phosphatase Flex® reagent cartridge, 360 tests CJO ALPHA-NAPHTHYL PHOSPHATE, ALKALINE PHOSPHATASE OR ISOENZYMES Dimension® Flex® reagent cartridge ALPI
2 00842768037740 10706480 RF634 Dimension® EXL™ Total Vitamin D, 200 tests (4x50) MRG SYSTEM, TEST, VITAMIN D Dimension® EXL™ Total Vitamin D
3 00842768037214 10636928 778041.931 Dimension® EXL™ 200 System JJE ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE 1 Dimension® EXL™ 200 Integrated Chemistry System
4 00842768034138 10470441 9R529UL Syva® Emit® II Plus 6-AM /Ecstasy Calibrator/Control Level 1 DKB,DIF CALIBRATORS, DRUG MIXTURE,DRUG MIXTURE CONTROL MATERIALS 1 Syva® Emit® II Plus 6-AM /Ecstasy Calibrator/Control Level 1
5 00842768033322 10636333 KC470 DGTX Calibrator, 2x5x5.0mL JIT CALIBRATOR, SECONDARY 2 Dimension Vista® DGTX CAL
6 00842768030413 10484429 K800A V-LYTE Integrated Multisensor CEM,JGS,CGZ ELECTRODE, ION SPECIFIC, POTASSIUM,ELECTRODE, ION SPECIFIC, SODIUM,ELECTRODE, IO ELECTRODE, ION SPECIFIC, POTASSIUM,ELECTRODE, ION SPECIFIC, SODIUM,ELECTRODE, ION-SPECIFIC, CHLORIDE 2 Dimension Vista® V-LYTE® Integrated Multisensor Na+ / K+ / Cl-
7 00842768030024 10472176 778021.931 Dimension® EXL with LM system JJE ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE 1 Dimension® EXL™ with LM Integrated Chemistry System
8 00842768029912 10464526 RF623 LOCI N-terminal Pro-Brain Natriuretic Peptide Flex® reagent cartridge, 120 tests NBC TEST,NATRIURETIC PEPTIDE Dimension® EXL™ LOCI® Module Flex® reagent cartridge NTP
9 00842768029332 10488446 KC605 LOCI 7 Calibrator, 2x5x2mL JIX CALIBRATOR, MULTI-ANALYTE MIXTURE 2 Dimension Vista® LOCI 7 CAL
10 00842768028915 10472099 KS860 Small Sample Container (SSC), 1000 Pieces JJE ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE Dimension Vista® Small Sample Container (SSC)
11 00842768027307 11306492 11306492 ADVIA 120/2120/2120i Vent Line Wash Kit JCB DETERGENT 1 ADVIA 120/2120/2120i Vent Line Wash Kit
12 00842768025556 10464510 DF32 Creatine Kinase MB Flex® reagent cartridge, 120 tests CGS NAD REDUCTION/NADH OXIDATION, CPK OR ISOENZYMES Dimension® Flex® reagent cartridge MBI
13 00842768025112 10464321 K6423A NT-proBNP Flex® reagent cartridge, 80 Tests NBC TEST,NATRIURETIC PEPTIDE Dimension Vista® Flex® reagent cartridge PBNP
14 00842768023453 10445476 9Q229 Emit® II Plus Methaqualone Assay labeled with the Beckman Coulter® name KXS RADIOIMMUNOASSAY, METHAQUALONE 2 Emit® II Plus Methaqualone Assay
15 00842768023354 10445415 9B229 Emit® II Plus Opiate Assay labeled with the Beckman Coulter® name DJG ENZYME IMMUNOASSAY, OPIATES 2 Emit® II Plus Opiate Assay
16 00842768022111 10464331 DF306 Sirolimus Flex® reagent cartridge, 80 tests NRP Sirolimus test system Dimension® Flex® reagent cartridge SIRO
17 00842768022050 10459408 DF22 Ethyl Alcohol Flex® reagent cartridge, 120 tests DIC ALCOHOL DEHYDROGENASE, SPECIFIC REAGENT FOR ETHANOL ENZYME METHOD Dimension® Flex® reagent cartridge ETOH
18 00842768016653 10445138 K6444 Folate Flex® reagent cartridge, 120 tests CGN ACID, FOLIC, RADIOIMMUNOASSAY Dimension Vista® Flex® reagent cartridge FOL
19 00842768016455 10445187 KC510 Drugs of Abuse Calibrator, 4x2.5mL / 2x2.6mL DKB CALIBRATORS, DRUG MIXTURE 2 Dimension Vista® UDAT CAL
20 00842768016028 10444897 RF434 CardioPhase® high sensitivity CRP Flex® reagent cartridge, 120 tests NQD CARDIAC C-REACTIVE PROTEIN, ANTIGEN, ANTISERUM, AND CONTROL Dimension CardioPhase high sensitivity CRP Flex reagent cartridge
21 00842768015731 10445104 K6412 Thyroid Stimulating Hormone Flex® reagent cartridge, 960 Tests JLW RADIOIMMUNOASSAY, THYROID-STIMULATING HORMONE Dimension Vista® Flex® reagent cartridge TSH
22 00842768015618 10445160 K1023 Calcium Flex® reagent cartridge, 1320 tests CIC CRESOLPHTHALEIN COMPLEXONE, CALCIUM Dimension Vista® Flex® reagent cartridge CA
23 00842768015496 10445102 K6075 Thyronine Uptake Flex® reagent cartridge, 160 tests KHQ RADIOASSAY, TRIIODOTHYRONINE UPTAKE Dimension Vista® Flex® reagent cartridge TU
24 00842768015328 10445097 K6420 Mass Creatine Kinase MB Isoenzyme Flex® reagent cartridge, 100 tests JHY COLORIMETRIC METHOD, CPK OR ISOENZYMES Dimension Vista® Flex® reagent cartridge MMB
25 00842768015281 10445132 K4113 Lidocaine Flex® reagent cartridge, 60 tests KLR ENZYME IMMUNOASSAY, LIDOCAINE Dimension Vista® Flex® reagent cartridge LIDO
26 00842768015199 10445106 K6416 Free Triiodothyronine Flex® reagent cartridge, 120 tests CDP RADIOIMMUNOASSAY, TOTAL TRIIODOTHYRONINE Dimension Vista® Flex® reagent cartridge FT3
27 00842768015090 10445143 K1027 Cholesterol Flex® reagent cartridge, 600 tests CHH ENZYMATIC ESTERASE--OXIDASE, CHOLESTEROL Dimension Vista® Flex® reagent cartridge CHOL
28 00842768014352 10445423 9D039UL Syva® Emit® II Plus Barbiturate Assay - 28 mL Kit KLT ENZYME IMMUNOASSAY, CARBAMAZEPINE 2 Syva® Emit® II Plus Barbiturate Assay
29 00842768014345 10445418 9C039UL Syva® Emit® II Plus Amphetamines Assay - 29 mL kit DKZ ENZYME IMMUNOASSAY, AMPHETAMINE 2 Syva® Emit® II Plus Amphetamines Assay
30 00842768014338 10445414 9B039UL Syva® Emit® II Plus Opiate Assay - 29 mL Kit DJG ENZYME IMMUNOASSAY, OPIATES 2 Syva® Emit® II Plus Opiate Assay
31 00842768014086 10445042 D828 Cuvette Cartridge - Dimension® - 1 Cartridge JJE ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE 1 Dimension® Cuvette Cartridge
32 00842768014024 10444872 S640 Quiklyte Diluent Check, 60mL CGZ,JGS,JFL,CEM ELECTRODE, ION-SPECIFIC, CHLORIDE,ELECTRODE, ION SPECIFIC, SODIUM,PH RATE MEASUR ELECTRODE, ION-SPECIFIC, CHLORIDE,ELECTRODE, ION SPECIFIC, SODIUM,PH RATE MEASUREMENT, CARBON-DIOXIDE,ELECTRODE, ION SPECIFIC, POTASSIUM 2 Dimension® QuikLYTE® Integrated Multisensor Diluent Check
33 00842768013911 10444914 RF530 Human Chorionic Gonadotropin Flex® reagent cartridge, 120 tests DHA SYSTEM, TEST, HUMAN CHORIONIC GONADOTROPIN Dimension Human Chorionic Gonadotropin Flex reagent cartridge
34 00842768013843 10444907 RF422A Myoglobin Flex® reagent cartridge, 120 tests DDR MYOGLOBIN, ANTIGEN, ANTISERUM, CONTROL Dimension® Heterogenous Immunoassay Module Flex® reagent cartridge MYO
35 00842768013775 10445035 RD703 Sample Probe Cleaner, 1x1 Liter JJE,JMG ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE,Radioimmunoassay ( ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE,Radioimmunoassay (two-site solid phase), ferritin 1 Dimension® Sample Probe Cleaner
36 00842768013720 10445024 RC422 Myoglobin Calibrator, 2x5x1mL JIT CALIBRATOR, SECONDARY Dimension® MYO Calibrator
37 00842768005848 10444924 DF94A Urine Phencyclidine Screen Flex® reagent cartridge, 80 tests LCM Enzyme immunoassay, phencyclidine Dimension® Flex® reagent cartridge PCP
38 00842768005527 10444894 DF37 C-Reactive Protein Flex® reagent cartridge, 120 tests DCK C-REACTIVE PROTEIN, ANTIGEN, ANTISERUM, AND CONTROL Dimension® Flex® reagent cartridge CRP
39 00842768005367 10444939 DF132 Lithium Flex® reagent cartridge, 80 tests JIH FLAME PHOTOMETRY, LITHIUM Dimension® Flex® reagent cartridge LI
40 00842768005275 10444948 DF11 Acid Phosphatase Flex® reagent cartridge, 120 tests CKE Acid phosphatase, thymolphthale inmonophosphate Dimension® Flex® reagent cartridge ACP
41 00842768005268 10444934 DF108 Cyclosporine Extended Range Flex® reagent cartridge, 80 tests MKW CYCLOSPORINE Dimension® Flex® reagent cartridge CSAE
42 00842768005183 10445025 DC50 Prealbumin Calibrator, 2x5x1mL JIT CALIBRATOR, SECONDARY Dimension® PALB Calibrator
43 00842768005091 10444993 DC31 Total Protein/Albumin Calibrator, 2x3x2mL JIX CALIBRATOR, MULTI-ANALYTE MIXTURE Dimension® TP/ALB Calibrator
44 00842768005084 10444988 DC30 C-Reactive Protein Calibrator, 2x5x1mL DCK C-REACTIVE PROTEIN, ANTIGEN, ANTISERUM, AND CONTROL Dimension® CRP Calibrator
45 00842768004445 10445064 CCANS Stratus® CS STAT Fluorometric Analyzer Sarstedt cannula holds the stoppered tube Stratus® CS STAT Fluorometric Analyzer Sarstedt cannula holds the stoppered tube in the sample manager. JHX FLUOROMETRIC METHOD, CPK OR ISOENZYMES Stratus® CS STAT Fluorometric Analyzer Cannula
46 00842768004438 10445063 CCANBD For the cannulation of B-D Vacutainer® 4 or 5 mL lithium heparin collection tube For the cannulation of B-D Vacutainer® 4 or 5 mL lithium heparin collection tubes, with HEMOGARD® closure, to be used on the Stratus® CS STAT Fluorometric Analyzer. JHX FLUOROMETRIC METHOD, CPK OR ISOENZYMES Stratus® CS STAT Fluorometric Analyzer Cannula
47 00630414600284 10995715 10995715 Vitamin B12 (VB12) Atellica IM - RGT 500T CDD RADIOASSAY, VITAMIN B12 Atellica IM VB12
48 00842768001888 10445424 9D129UL Syva® Emit® II Plus Barbiturate Assay - 1 L Kit KLT ENZYME IMMUNOASSAY, CARBAMAZEPINE 2 Syva® Emit® II Plus Barbiturate Assay
49 00842768001871 10445422 9D029UL Syva® Emit® II Plus Barbiturate Assay - 115 mL Kit KLT ENZYME IMMUNOASSAY, CARBAMAZEPINE 2 Syva® Emit® II Plus Barbiturate Assay
50 00842768001864 10445421 9C329UL Syva® Emit® II Plus Amphetamines Assay - 1L Kit DKZ ENZYME IMMUNOASSAY, AMPHETAMINE 2 Syva® Emit® II Plus Amphetamines Assay
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.
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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
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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
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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.
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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