| Primary Device ID | 10811877010347 |
| NIH Device Record Key | a1bd1a7b-2d2f-4d3f-8e2a-4129169846e2 |
| Commercial Distribution Discontinuation | 2024-03-23 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Alere Determine™ HIV–1/2 Ag/Ab Combo Controls |
| Version Model Number | 7D2628 |
| Company DUNS | 154148498 |
| Company Name | Alere Scarborough, 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 | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10811877010347 [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 | 3 |
| Public Version Date | 2023-09-12 |
| Device Publish Date | 2017-05-11 |
| 10811877010545 - Alere NMP22 Test | 2023-09-14 For the in vitro quantitative measurement of the Nuclear Matrix Protein NMP22 in stabilized urine (ELISA). |
| 10811877010606 - Alere NMP22 BladderChek Control Kit | 2023-09-14 The Alere NMP22 BladderChek Control Kit consists of a Negative and a Positive Control solution for use as an external control fo |
| 10811877010637 - Alere NMP22® Urine Collection Kit | 2023-09-14 The Alere NMP22® Urine Collection Kit is intended for the collection, stabilization, and transport of human urine which will b |
| 10811877010798 - DIGIVAL Calibration Check Card Pack | 2023-09-14 A calibration check card verifies that the DIGIVAL is functioning correctly |
| 00811877011477 - BinaxNOW COVID-19 Antigen Self Test | 2023-09-13 A rapid test for the qualitative detection of COVID-19 antigens in nasal swab specimens. |
| 00811877011507 - BinaxNOW COVID-19 Antigen Self Test | 2023-09-13 A rapid test for the qualitative detection of COVID-19 antigens in nasal swab specimens. |
| 00811877011798 - BinaxNOW COVID-19 Antigen Self Test | 2023-09-13 A rapid test for the qualitative detection of COVID-19 antigens in nasal swab specimens. |
| 10811877010019 - Alere i Influenza A & B 2 | 2023-09-12 A rapid, automated, molecular test for the qualitative detection of influenza A and B viral nucleic acid in respiratory specimen |