| Primary Device ID | 00848838077135 |
| NIH Device Record Key | 96b0d7b7-00cd-4252-a351-f707587d8e5f |
| Commercial Distribution Status | In Commercial Distribution |
| Version Model Number | R01173 |
| Company DUNS | 065769564 |
| Company Name | REMEL, INC. |
| Device Count | 10 |
| DM Exempt | false |
| 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 | false |
| 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 | 8002556730 |
| ITechnicalSupport@remel.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00848838077135 [Primary] |
| GS1 | 00848838099427 [Unit of Use] |
| JSO | Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar |
| 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 | 2016-09-24 |
| 00842558116709 - Spectra™ Candida Agar | 2026-02-17 |
| 00848838072772 - MicroTest M6 | 2026-02-17 M6 (1.5ml) Universal Swab Kit PK/100 |
| 00848838074844 - MicroTest M4RT | 2026-02-17 M4RT(3ml) Universal Flock Swab Kit PK/100 |
| 00848838075018 - MicroTest M6 | 2026-02-17 M6(1.5ml) Traditional FlockSwab KitPK/100 |
| 00848838091742 - VersaTREK™ | 2026-02-04 |
| 00848838003158 - Strep Selective II Agar | 2026-01-26 |
| 00848838059865 - ^BM^ PK/50 OXIDASE TEST | 2026-01-26 ^BM^ PK/50 OXIDASE TEST |
| 00842558116402 - BactiSwab Dry PK/100 | 2025-06-27 |