| Primary Device ID | 10608337103400 |
| NIH Device Record Key | 5c176c94-2ea1-4168-bfe9-2767348f799c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | OraQuick In Home HIV Test |
| Version Model Number | 1001-0340 |
| Company DUNS | 114152184 |
| Company Name | Orasure Technologies, Inc. |
| Device Count | 1 |
| DM Exempt | true |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| 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 | true |
| Phone | 610-882-1820 |
| customercare@orasure.com | |
| Phone | 610-882-1820 |
| customercare@orasure.com | |
| Phone | 610-882-1820 |
| customercare@orasure.com |
| Storage Environment Temperature | Between 2 Degrees Celsius and 27 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 27 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 27 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00608337000948 [Package] Contains: 00608337103403 Package: display [4 Units] In Commercial Distribution |
| GS1 | 00608337103403 [Primary] |
| GS1 | 10608337103400 [Package] Contains: 00608337103403 Package: carton [6 Units] In Commercial Distribution |
| GS1 | 20608337103407 [Package] Contains: 00608337103403 Package: display [4 Units] In Commercial Distribution |
| MZF | Test, Hiv Detection |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-03-29 |
| Device Publish Date | 2014-09-05 |
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| 20608337000065 - OraSure Quick Flu 22-Count Flu A + B Kit | 2018-07-06 |
| 00608337000009 - OraQuick Advance HIV 1/2 Kit Controls | 2018-07-06 |
| 20608337000010 - OraQuick Advance Rapid HIV 1/2 Antibody Test | 2018-07-06 |