| Primary Device ID | 00847865001946 |
| NIH Device Record Key | 912a09ab-a1f7-426c-bc6b-192423f5ceba |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | GS |
| Version Model Number | 32589 |
| Catalog Number | 32589 |
| Company DUNS | 844766394 |
| Company Name | Bio-RAD Laboratories, Inc. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | true |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Phone | +1(800)224-6723 |
| techsupport.ussd-redmond@bio-rad.com | |
| Phone | +1(800)224-6723 |
| techsupport.ussd-redmond@bio-rad.com | |
| Phone | +1(800)224-6723 |
| techsupport.ussd-redmond@bio-rad.com | |
| Phone | +1(800)224-6723 |
| techsupport.ussd-redmond@bio-rad.com | |
| Phone | +1(800)224-6723 |
| techsupport.ussd-redmond@bio-rad.com | |
| Phone | +1(800)224-6723 |
| techsupport.ussd-redmond@bio-rad.com | |
| Phone | +1(800)224-6723 |
| techsupport.ussd-redmond@bio-rad.com | |
| Phone | +1(800)224-6723 |
| techsupport.ussd-redmond@bio-rad.com | |
| Phone | +1(800)224-6723 |
| techsupport.ussd-redmond@bio-rad.com | |
| Phone | +1(800)224-6723 |
| techsupport.ussd-redmond@bio-rad.com | |
| Phone | +1(800)224-6723 |
| techsupport.ussd-redmond@bio-rad.com | |
| Phone | +1(800)224-6723 |
| techsupport.ussd-redmond@bio-rad.com | |
| Phone | +1(800)224-6723 |
| techsupport.ussd-redmond@bio-rad.com | |
| Phone | +1(800)224-6723 |
| techsupport.ussd-redmond@bio-rad.com | |
| Phone | +1(800)224-6723 |
| techsupport.ussd-redmond@bio-rad.com | |
| Phone | +1(800)224-6723 |
| techsupport.ussd-redmond@bio-rad.com |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00847865001946 [Primary] |
| MZF | Test, Hiv Detection |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2020-01-23 |
| Device Publish Date | 2014-08-22 |
| 00847865018845 | Plate Sealers 25/pkg x 40pkgs |
| 00847865013253 | GS HIV Combo Ag/Ab EIA, Conjugate 2 Diluent, 40 mL |
| 00847865013246 | GS HIV Combo Ag/Ab EIA, Conjugate 2, Lyophilized, 40 mL |
| 00847865013239 | GS HIV Combo Ag/Ab EIA, Conjugate 2, Lyophilized, 18 mL |
| 00847865013222 | GS HIV Combo Ag/Ab EIA, Conjugate 1, 10 mL |
| 00847865013215 | GS HIV Combo Ag/Ab EIA, Cutoff Calibrator, 1.7 mL |
| 00847865013208 | GS HIV Combo Ag/Ab EIA, HIV-2/O Ab Pos Ctrl, 1.5 mL |
| 00847865013192 | GS HIV Combo Ag/Ab EIA, HIV-1 Ab Pos Ctrl, 1.5 mL |
| 00847865013185 | GS HIV Combo Ag/Ab EIA, Negative Control, 1.5 mL |
| 00847865011563 | Human Immunodeficiency Virus Type 2, GS HIV-2 EIA, 480-Test Kit |
| 00847865010672 | GS HIV Combo Ag/Ab EIA, HIV Ag Pos Ctrl, 1.5 mL |
| 00847865010665 | GS HIV Combo Ag/Ab EIA, 960 Tests |
| 00847865010658 | GS HIV Combo Ag/Ab EIA, 192 Tests |
| 00847865003063 | HIV-1 Western Blot, Strip Folder 10/pkg |
| 00847865003056 | HIV-1 Western Blot, Strip Worksheet 50/pkg |
| 00847865003049 | Human Immunodeficiency Virus Type 1 GS HIV-1 Western Blot, (40 Tests) |
| 00847865002752 | HIV-1 Western Blot, Specimen Diluent/Wash (5X), 100 mL |
| 00847865002028 | HIV-1/HIV-2 PLUS O EIA Specimen Diluent, 100 mL |
| 00847865002011 | HIV-1/HIV-2 PLUS O EIA Conjugate Concentrate, 12 mL |
| 00847865002004 | HIV-1/HIV-2 PLUS O EIA Conjugate Diluent, 120 mL |
| 00847865001991 | HIV-1/HIV-2 PLUS O EIA HIV-1 Group O Positive Control, 1.4 mL |
| 00847865001984 | HIV-1/HIV-2 PLUS O EIA HIV-2 Positive Control, 1.4 mL |
| 00847865001977 | HIV-1/HIV-2 PLUS O EIA HIV-1 Positive Control, 1.4 mL |
| 00847865001960 | HIV-1/HIV-2 PLUS O EIA HIV Negative Control, 8 mL |
| 00847865001953 | Human Immunodeficiency Virus Types 1 and 2 (Recombinant and Synthetic Peptide) GS HIV-1/HIV-2 P |
| 00847865001946 | Human Immunodeficiency Virus Types 1 and 2 (Recombinant and Synthetic Peptide) GS HIV-1/HIV-2 PL |
| 00847865001939 | Human Immunodeficiency Virus Types 1 and 2 (Recombinant and Synthetic Peptide) GS HIV-1/HIV-2 PL |
| 00847865001922 | Antibody to Hepatitis B Surface Antigen (Human) GS HBsAg 3.0 - HBsAg Confirmatory Assay 3.0 |
| 00847865001892 | HBsAg EIA 3.0 Low Positive Control, 8 mL |
| 00847865001885 | HBsAg EIA 3.0 Positive Control, 8 mL |
| 00847865001878 | HBsAg EIA 3.0 Negative Control, 12 mL |
| 00847865001861 | HBsAg EIA 3.0 Conjugate Diluent, 120 mL |
| 00847865001854 | HBsAg EIA 3.0 Conjugate Concentrate, 1.2 mL |
| 00847865001847 | Antibody to Hepatitis B Surface Antigen (Mouse Monoclonal) GS HBsAg EIA 3.0 4800 Tests |
| 00847865001830 | Antibody to Hepatitis B Surface Antigen (Mouse Monoclonal) GS HBsAg EIA 3.0 960 Tests |
| 00847865001823 | Antibody to Hepatitis B Surface Antigen (Mouse Monoclonal) GS HBsAg EIA 3.0 480 Tests |
| 03610522112777 | GS HIV Combo Ag/Ab EIA, 192 Tests |
| 03610522112791 | GS HIV Combo Ag/Ab EIA, 4800 Tests |
| 03610522112784 | GS HIV Combo Ag/Ab, 960 Tests |
| 03610522110414 | Conjugate 2 Diluent, GS HIV Combo Ag/Ab, 120mL |
| 03610522110209 | Conjugate 2, GS HIV Combo Ag/Ab, 12 mL |
| 03610520179871 | GS HIV Combo Ag/Ab EIA, 4800 Tests |
| 03610520505304 | Western Blot Trays & Lids 8/pkg |