No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
---|---|---|---|---|---|---|---|---|
1 | 00847865013178 | 26203 | 26203 | Anti-HBc IgM EIA, Cutoff Calibrator, 1.5 mL | LOM | Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm) | 3 | MONOLISA™ |
2 | 00847865013161 | 26202 | 26202 | Anti-HBc IgM EIA, Conjugate, Lyophilized, 7.5 mL | LOM | Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm) | 3 | MONOLISA™ |
3 | 00847865013154 | 26201 | 26201 | Anti-HBc IgM EIA, Negative Control, 0.8 mL | LOM | Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm) | 3 | MONOLISA™ |
4 | 00847865013147 | 26200 | 26200 | Anti-HBc IgM EIA, Positive Control,1.6 mL | LOM | Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm) | 3 | MONOLISA™ |
5 | 00847865013130 | 26199 | 26199 | Anti-HBc IgM EIA, Specimen Diluent, 30 mL | LOM | Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm) | 3 | MONOLISA™ |
6 | 00847865013123 | 26198 | 26198 | Anti-HBc IgM EIA Conjugate Diluent, 30 mL | LOM | Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm) | 3 | MONOLISA™ |
7 | 00847865013116 | 26197 | 26197 | Anti-HBc EIA, Negative Control, 0.8 mL | LOM | Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm) | 3 | MONOLISA™ |
8 | 00847865013109 | 26196 | 26196 | Anti-HBc EIA, Specimen Diluent, 30 mL | LOM | Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm) | 3 | MONOLISA™ |
9 | 00847865013093 | 26195 | 26195 | Anti-HBc EIA, Cutoff Calibrator, 1.5 mL | LOM | Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm) | 3 | MONOLISA™ |
10 | 00847865013086 | 26194 | 26194 | Anti-HBc EIA, Positive Control, 0.8 mL | LOM | Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm) | 3 | MONOLISA™ |
11 | 00847865013079 | 26193 | 26193 | Anti-HBc EIA, Conjugate Reagent 30 mL | LOM | Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm) | 3 | MONOLISA™ |
12 | 00847865011372 | 26186 | 26186 | MONOLISA™ Anti-HBc EIA 192 Tests | LOM | Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm) | 3 | MONOLISA™ |
13 | 00847865011365 | 26174 | 26174 | MONOLISA™ Anti-HBc IgM EIA, 192 Tests | LOM | Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm) | 3 | MONOLISA™ |
14 | 00847865002110 | 26156 | 26156 | Anti-HBs EIA, Specimen Diluent 10 mL | LOM | Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm) | 3 | MONOLISA™ |
15 | 00847865002103 | 26155 | 26155 | Anti-HBs EIA, Conjugate Diluent 15 mL | LOM | Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm) | 3 | MONOLISA™ |
16 | 00847865002097 | 26154 | 26154 | Anti-HBs EIA, 10 mIU/mL Calibrator 1.8 mL | LOM | Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm) | 3 | MONOLISA™ |
17 | 00847865002080 | 26153 | 26153 | Anti-HBs EIA, Negative Control 1.5 mL | LOM | Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm) | 3 | MONOLISA™ |
18 | 00847865002073 | 26152 | 26152 | Anti-HBs EIA, Positive Control 1.5 mL | LOM | Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm) | 3 | MONOLISA™ |
19 | 00847865002066 | 26151 | 26151 | Anti-HBs EIA Hepatitis B Surface Antigen (Human) Horeseradish Peroxidase Conjugate | LOM | Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm) | 3 | MONOLISA™ |
20 | 00847865002042 | 25219 | 25219 | MONOLISA™ Anti-HBs EIA Calibrator Kit | LOM | Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm) | 3 | MONOLISA™ |
21 | 00847865001687 | 31996 | 31996 | Kallestad Patient Sample Diluent | DBM | ANTIMITOCHONDRIAL ANTIBODY, INDIRECT IMMUNOFLUORESCENT, ANTIGEN, CONTROL | 2 | Kallestad |
22 | 00847865001670 | 26106 | 26106 | Kallestad HEp-2 Cell Line 24 Well Slides | DBM | ANTIMITOCHONDRIAL ANTIBODY, INDIRECT IMMUNOFLUORESCENT, ANTIGEN, CONTROL | 2 | Kallestad |
23 | 00847865001779 | 30480 | 30480 | Kallestad FITC Conjugate | DBM | ANTIMITOCHONDRIAL ANTIBODY, INDIRECT IMMUNOFLUORESCENT, ANTIGEN, CONTROL | 2 | Kallestad |
24 | 00847865001762 | 30446 | 30446 | Kallestad FITC Conjugate | DBM | ANTIMITOCHONDRIAL ANTIBODY, INDIRECT IMMUNOFLUORESCENT, ANTIGEN, CONTROL | 2 | Kallestad |
25 | 00847865001755 | 30431 | 30431 | Kallestad Evans' Blue Counterstain | DBM | ANTIMITOCHONDRIAL ANTIBODY, INDIRECT IMMUNOFLUORESCENT, ANTIGEN, CONTROL | 2 | Kallestad |
26 | 00847865001724 | 26115 | 26115 | Kallestad Mouse Stomach/Kidney 8 Well Slides | DHN | ANTINUCLEAR ANTIBODY, INDIRECT IMMUNOFLUORESCENT, ANTIGEN, CONTROL | 2 | Kallestad |
27 | 00847865001717 | 26112 | 26112 | Kallestad Mouse Stomach/Kidney 8 Well Slides | DHN | ANTINUCLEAR ANTIBODY, INDIRECT IMMUNOFLUORESCENT, ANTIGEN, CONTROL | 2 | Kallestad |
28 | 00847865001700 | 26111 | 26111 | Kallestad Mouse Stomach/Kidney 8 Well Slides | DHN | ANTINUCLEAR ANTIBODY, INDIRECT IMMUNOFLUORESCENT, ANTIGEN, CONTROL | 2 | Kallestad |
29 | 00847865001694 | 30443 | 30443 | Kallestad Mouse Stomach Kidney Substrate | DHN | ANTINUCLEAR ANTIBODY, INDIRECT IMMUNOFLUORESCENT, ANTIGEN, CONTROL | 2 | Kallestad |
30 | 00847865001656 | 26104 | 26104 | Kallestad HEp-2 Cell Line 12 Well Slides | DBM | ANTIMITOCHONDRIAL ANTIBODY, INDIRECT IMMUNOFLUORESCENT, ANTIGEN, CONTROL | 2 | Kallestad |
31 | 00847865001649 | 26103 | 26103 | Kallestad HEp-2 Cell Line 12 Well Slides | DBM | ANTIMITOCHONDRIAL ANTIBODY, INDIRECT IMMUNOFLUORESCENT, ANTIGEN, CONTROL | 2 | Kallestad |
32 | 00847865001632 | 26102 | 26102 | Kallestad HEp-2 Cell Line 12 Well Slides | DBM | ANTIMITOCHONDRIAL ANTIBODY, INDIRECT IMMUNOFLUORESCENT, ANTIGEN, CONTROL | 2 | Kallestad |
33 | 00847865001625 | 26101 | 26101 | Kallestad HEp-2 Cell Line 6 Well Slides | DBM | ANTIMITOCHONDRIAL ANTIBODY, INDIRECT IMMUNOFLUORESCENT, ANTIGEN, CONTROL | 2 | Kallestad |
34 | 00847865001618 | 26100 | 26100 | Kallestad HEp-2 Cell Line 6 Well Slides | DBM | ANTIMITOCHONDRIAL ANTIBODY, INDIRECT IMMUNOFLUORESCENT, ANTIGEN, CONTROL | 2 | Kallestad |
35 | 00847865001601 | 30472 | 30472 | Kallestad HEp-2 Cell Line Substrate | DBM | ANTIMITOCHONDRIAL ANTIBODY, INDIRECT IMMUNOFLUORESCENT, ANTIGEN, CONTROL | 2 | Kallestad |
36 | 00847865001595 | 30471 | 30471 | Kallestad HEp-2 Cell Line Substrate | DBM | ANTIMITOCHONDRIAL ANTIBODY, INDIRECT IMMUNOFLUORESCENT, ANTIGEN, CONTROL | 2 | Kallestad |
37 | 00847865001588 | 32583 | 32583 | Kallestad HEp-2 Cell Line Substrate | DBM | ANTIMITOCHONDRIAL ANTIBODY, INDIRECT IMMUNOFLUORESCENT, ANTIGEN, CONTROL | 2 | Kallestad |
38 | 00847865001571 | 26110 | 26110 | Kallestad Crithidia luciliae 8 Well Slides | DHN | ANTINUCLEAR ANTIBODY, INDIRECT IMMUNOFLUORESCENT, ANTIGEN, CONTROL | 2 | Kallestad |
39 | 00847865001564 | 26109 | 26109 | Kallestad Crithidia luciliae 8 Well Slides | DHN | ANTINUCLEAR ANTIBODY, INDIRECT IMMUNOFLUORESCENT, ANTIGEN, CONTROL | 2 | Kallestad |
40 | 00847865001557 | 26108 | 26108 | Kallestad Crithidia luciliae 4 Well Slides | DHN | ANTINUCLEAR ANTIBODY, INDIRECT IMMUNOFLUORESCENT, ANTIGEN, CONTROL | 2 | Kallestad |
41 | 00847865001540 | 26107 | 26107 | Kallestad Crithidia luciliae 4 Well Slides | DHN | ANTINUCLEAR ANTIBODY, INDIRECT IMMUNOFLUORESCENT, ANTIGEN, CONTROL | 2 | Kallestad |
42 | 00847865001533 | 31069 | 31069 | Kallestad Crithidia luciliae Substrate | DHN | ANTINUCLEAR ANTIBODY, INDIRECT IMMUNOFLUORESCENT, ANTIGEN, CONTROL | 2 | Kallestad |
43 | 00847865001526 | 30404 | 30404 | Kallestad Crithidia luciliae Substrate | DHN | ANTINUCLEAR ANTIBODY, INDIRECT IMMUNOFLUORESCENT, ANTIGEN, CONTROL | 2 | Kallestad |
44 | 00847865001496 | 32514 | 32514 | MONOFLUO Legionella pneumophila IFA Test Kit | LHL | REAGENTS, ANTIBODY, LEGIONELLA, DIRECT & INDIRECT FLUORESCENT | 2 | Kallestad |
45 | 00847865001205 | 30403 | 30403 | Kallestad Mounting Media | DBM | ANTIMITOCHONDRIAL ANTIBODY, INDIRECT IMMUNOFLUORESCENT, ANTIGEN, CONTROL | 2 | Kallestad |
46 | 00847865019347 | 12000667 | 12000667 | Slide Blotters, 8-well | DHN | ANTINUCLEAR ANTIBODY, INDIRECT IMMUNOFLUORESCENT, ANTIGEN, CONTROL | 2 | Bio-Rad Laboratories, Inc. |
47 | 00847865019354 | 12000668 | 12000668 | Slide Blotters, 24-well | DBM | ANTIMITOCHONDRIAL ANTIBODY, INDIRECT IMMUNOFLUORESCENT, ANTIGEN, CONTROL | 2 | Bio-Rad Laboratories, Inc. |
48 | 00847865019330 | 12000666 | 12000666 | Slide Blotters, 4-well | DHN | ANTINUCLEAR ANTIBODY, INDIRECT IMMUNOFLUORESCENT, ANTIGEN, CONTROL | 2 | Bio-Rad Laboratories, Inc. |
49 | 00847865017343 | 12000660 | 12000660 | Slide Blotters, 6-well | DBM | ANTIMITOCHONDRIAL ANTIBODY, INDIRECT IMMUNOFLUORESCENT, ANTIGEN, CONTROL | 2 | Bio-Rad Laboratories, Inc. |
50 | 00847865017244 | 12000661 | 12000661 | Slide Blotters, 12-well | DBM | ANTIMITOCHONDRIAL ANTIBODY, INDIRECT IMMUNOFLUORESCENT, ANTIGEN, CONTROL | 2 | Bio-Rad Laboratories, Inc. |
No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
---|---|---|---|---|---|---|
1 | 00847865019255 | 6653455 | 6653455 | BioPlex 2200 HIV Ag-Ab Reagent Pack | BioPlex® 2200 | BIO-RAD LABORATORIES, INC. |
2 | 00847865018845 | 0210-00 | 0210-00 | Plate Sealers 25/pkg x 40pkgs | GS | BIO-RAD LABORATORIES, INC. |
3 | 00847865018487 | 6633440 | 6633440 | BioPlex 2200, HIV Ag-Ab Control Lot Data | BioPlex® 2200 | BIO-RAD LABORATORIES, INC. |
4 | 00847865018470 | 6633420 | 6633420 | BioPlex 2200, HIV Ag-Ab Calibrator Lot Data | BioPlex® 2200 | BIO-RAD LABORATORIES, INC. |
5 | 00847865018456 | 26166 | 26166 | MULTISPOT HIV-1/HIV-2 Rapid Test Negative Control Serum (Human) 1.0 mL | Bio-Rad | BIO-RAD LABORATORIES, INC. |
6 | 00847865013253 | 26228 | 26228 | GS HIV Combo Ag/Ab EIA, Conjugate 2 Diluent, 40 mL | GS | BIO-RAD LABORATORIES, INC. |
7 | 00847865013246 | 26227 | 26227 | GS HIV Combo Ag/Ab EIA, Conjugate 2, Lyophilized, 40 mL | GS | BIO-RAD LABORATORIES, INC. |
8 | 00847865013239 | 26226 | 26226 | GS HIV Combo Ag/Ab EIA, Conjugate 2, Lyophilized, 18 mL | GS | BIO-RAD LABORATORIES, INC. |
9 | 00847865013222 | 26225 | 26225 | GS HIV Combo Ag/Ab EIA, Conjugate 1, 10 mL | GS | BIO-RAD LABORATORIES, INC. |
10 | 00847865013215 | 26224 | 26224 | GS HIV Combo Ag/Ab EIA, Cutoff Calibrator, 1.7 mL | GS | BIO-RAD LABORATORIES, INC. |
11 | 00847865013208 | 26222 | 26222 | GS HIV Combo Ag/Ab EIA, HIV-2/O Ab Pos Ctrl, 1.5 mL | GS | BIO-RAD LABORATORIES, INC. |
12 | 00847865013192 | 26221 | 26221 | GS HIV Combo Ag/Ab EIA, HIV-1 Ab Pos Ctrl, 1.5 mL | GS | BIO-RAD LABORATORIES, INC. |
13 | 00847865013185 | 26220 | 26220 | GS HIV Combo Ag/Ab EIA, Negative Control, 1.5 mL | GS | BIO-RAD LABORATORIES, INC. |
14 | 00847865011563 | 32536 | 32536 | Human Immunodeficiency Virus Type 2, GS HIV-2 EIA, 480-Test Kit | GS | BIO-RAD LABORATORIES, INC. |
15 | 00847865011105 | 6600306 | 6600306 | BioPlex® 2200 Manual Reagent Pack Piercer | BioPlex® 2200 | BIO-RAD LABORATORIES, INC. |
16 | 00847865010672 | 26223 | 26223 | GS HIV Combo Ag/Ab EIA, HIV Ag Pos Ctrl, 1.5 mL | GS | BIO-RAD LABORATORIES, INC. |
17 | 00847865010665 | 26218 | 26218 | GS HIV Combo Ag/Ab EIA, 960 Tests | GS | BIO-RAD LABORATORIES, INC. |
18 | 00847865010658 | 26217 | 26217 | GS HIV Combo Ag/Ab EIA, 192 Tests | GS | BIO-RAD LABORATORIES, INC. |
19 | 00847865002745 | 25228 | 25228 | MULTISPOT HIV-1/HIV-2 Rapid Test 50 Tests | Bio-Rad | BIO-RAD LABORATORIES, INC. |
20 | 00847865002028 | 25123 | 25123 | HIV-1/HIV-2 PLUS O EIA Specimen Diluent, 100 mL | GS | BIO-RAD LABORATORIES, INC. |
21 | 00847865002011 | 25122 | 25122 | HIV-1/HIV-2 PLUS O EIA Conjugate Concentrate, 12 mL | GS | BIO-RAD LABORATORIES, INC. |
22 | 00847865002004 | 25121 | 25121 | HIV-1/HIV-2 PLUS O EIA Conjugate Diluent, 120 mL | GS | BIO-RAD LABORATORIES, INC. |
23 | 00847865001991 | 25120 | 25120 | HIV-1/HIV-2 PLUS O EIA HIV-1 Group O Positive Control, 1.4 mL | GS | BIO-RAD LABORATORIES, INC. |
24 | 00847865001984 | 25119 | 25119 | HIV-1/HIV-2 PLUS O EIA HIV-2 Positive Control, 1.4 mL | GS | BIO-RAD LABORATORIES, INC. |
25 | 00847865001977 | 25118 | 25118 | HIV-1/HIV-2 PLUS O EIA HIV-1 Positive Control, 1.4 mL | GS | BIO-RAD LABORATORIES, INC. |
26 | 00847865001960 | 25117 | 25117 | HIV-1/HIV-2 PLUS O EIA HIV Negative Control, 8 mL | GS | BIO-RAD LABORATORIES, INC. |
27 | 00847865001953 | 25256 | 25256 | Human Immunodeficiency Virus Types 1 and 2 (Recombinant and Synthetic Peptide) Human Immunodeficiency Virus Types 1 and 2 (Recombinant and Synthetic Peptide) GS HIV-1/HIV-2 PLUS O EIA 4800 Test Kit | GS | BIO-RAD LABORATORIES, INC. |
28 | 00847865001946 | 32589 | 32589 | Human Immunodeficiency Virus Types 1 and 2 (Recombinant and Synthetic Peptide) G Human Immunodeficiency Virus Types 1 and 2 (Recombinant and Synthetic Peptide) GS HIV-1/HIV-2 PLUS O EIA 960 Test Kit | GS | BIO-RAD LABORATORIES, INC. |
29 | 00847865001939 | 32588 | 32588 | Human Immunodeficiency Virus Types 1 and 2 (Recombinant and Synthetic Peptide) G Human Immunodeficiency Virus Types 1 and 2 (Recombinant and Synthetic Peptide) GS HIV-1/HIV-2 PLUS O EIA 480 Test Kit | GS | BIO-RAD LABORATORIES, INC. |
30 | 00847865001816 | 26182 | 26182 | Chromogen:TMB Solution 1:11 12 mL | Bio-Rad | BIO-RAD LABORATORIES, INC. |
31 | 00847865001809 | 26181 | 26181 | Substrate Buffer TMB buf., 120 mL | Bio-Rad | BIO-RAD LABORATORIES, INC. |
32 | 00847865001793 | 25260 | 25260 | STOP Stopping Solution 1N 15 x 120 mL | Bio-Rad | BIO-RAD LABORATORIES, INC. |
33 | 00847865001786 | 25261 | 25261 | Wash Solution Concentrate (30X), 15 x 120 mL | Bio-Rad | BIO-RAD LABORATORIES, INC. |
34 | 00847865001281 | SW4.2_v4 | 665-3465A | U.S. IFU Manual and CDs, BioPlex 2200 HIV Ag-Ab IFU 665-3465A | BioPlex® 2200 | BIO-RAD LABORATORIES, INC. |
35 | 00686597010310 | 90-1031 | 90-1031 | INSTI HIV-1/HIV-2 Control Test Kit | INSTI HIV-1/HIV-2 Control Test Kit | BIOLYTICAL LABORATORIES INC |
36 | 00686597010303 | 90-1030 | 90-1030 | INSTI HIV-1 Control Test Kit | INSTI HIV-1 Control Test Kit | BIOLYTICAL LABORATORIES INC |
37 | 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 |
38 | 00630414600390 | 10995459 | 10995459 | CHIV - Atellica IM - RGT - 100T | Atellica IM CHIV | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
39 | 00630414599342 | 10995611 | 10995611 | HIV 1/O/2 (eHIV) - Atellica IM - RGT - 200T | Atellica IM EHIV | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
40 | 00630414598550 | 10995528 | 10995528 | CHIV QC Kit Atellica IM - CLT 5 x 1 x 15.0mL | Atellica IM CHIV QC | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
41 | 00630414590202 | 10697214 | 10697214 | ADVIA Centaur® CHIV Quality Control Material | ADVIA Centaur® CHIV QC | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
42 | 00630414589749 | 10696880 | 10696880 | ADVIA Centaur® CHIV assay (100 tests) | ADVIA Centaur® CHIV | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
43 | 00630414511245 | 10332613 | 1622429 | HIV 1/O/2 Enhanced (EHIV) (1-pack) 200T Assay Kit | ADVIA Centaur® EHIV | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
44 | 00630414509372 | 10309010 | 1324827 | HIV 1/O/2 Enhanced (EHIV) Quality Control Material Kit | ADVIA Centaur® Systems EHIV QC | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
45 | 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. |
46 | 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. |
47 | 00630414301280 | 11207266 | 11207266 | CHIV - Atellica IM - RGT - 100T | Atellica IM CHIV | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
48 | 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 | |
49 | 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 | |
50 | 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 |