Primary Device ID | 00848838074530 |
NIH Device Record Key | 91f2cff5-c94a-4930-982b-f47841861185 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Sensititire® OptiRead™ |
Version Model Number | V3030 |
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 | true |
Manufacturing Date | false |
Expiration Date | false |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | true |
OTC Over-The-Counter | false |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00848838074530 [Primary] |
LRG | Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2023-06-28 |
Device Publish Date | 2023-06-20 |
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 |
00848838004742 - REMEL | 2024-05-13 PRAS Cooked Meat Glucose (7.5ml) 20/PK |
00848838009075 - REMEL | 2024-05-13 Phos Buffered Saline (5ml) 100/PK |
00848838009747 - REMEL | 2024-05-13 Selenite Broth (9ml) 100/PK |
00848838009754 - REMEL | 2024-05-13 Selenite Broth (9ml) 20/PK |