Primary Device ID | 00848838026904 |
NIH Device Record Key | 279e753d-8a20-43cf-904d-4a53bbd6464d |
Commercial Distribution Status | In Commercial Distribution |
Version Model Number | R2451030 |
Company DUNS | 065769564 |
Company Name | REMEL, INC. |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | true |
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 | 00848838026904 [Primary] |
MHJ | Cryptosporidium Spp. |
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 |
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 |