| Primary Device ID | 00848838057991 |
| NIH Device Record Key | c09d7b5a-9bf5-47d1-a0b1-8f0ffb4af3d7 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Remel Inc |
| Version Model Number | R8311001 |
| Company DUNS | 065769564 |
| Company Name | REMEL, INC. |
| Device Count | 20 |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00848838057991 [Primary] |
| GS1 | 03848838057998 [Unit of Use] |
| GS1 | 30848838057992 [Unit of Use] |
| JSX | Kit, Identification, Neisseria Gonorrhoeae |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-11-22 |
| Device Publish Date | 2021-11-12 |
| 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 |