| 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 |
| 00842558116419 - ACT I Transport PK/10 | 2024-08-14 |
| 00842558116426 - ACT II Transport PK/10 | 2024-08-14 |
| 00842558116433 - ACT II Dual Transport PK/10 | 2024-08-14 |
| 05032384519903 - ProSpecT | 2024-08-06 ProSpecT C. diff Toxin A/B MP KT/96TST |
| 00848838002724 - REMEL | 2024-05-14 Pseudomonas P Agar 10/PK |
| 00848838009921 - REMEL | 2024-05-14 Thio Med w/o Ind, w/o Dex (5ml) 100/PK |
| 00848838009938 - REMEL | 2024-05-14 Thio Med w/o Ind, w/o Dex (5ml) 20/PK |
| 00848838001994 - REMEL | 2024-05-13 KBE (Kanamycin Bile Esculin) Agar 15/PK |