| Primary Device ID | 00848838080913 |
| NIH Device Record Key | f9010a7f-1776-4f12-813b-e69eb5221b69 |
| Commercial Distribution Status | In Commercial Distribution |
| Version Model Number | R30851502 |
| Company DUNS | 065769564 |
| Company Name | REMEL, 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 | 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 | 00848838080913 [Primary] |
| GMD | Antisera, Latex Agglutination, Cryptococcus Neoformans |
| 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 |
| 00848838003240 - REMEL | 2024-11-07 Tergitol 7 Agar w/TTC 10/PK |
| 00848838007736 - REMEL | 2024-11-07 Lysozyme Broth (5ml) 20/PK |
| 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 |