Primary Device ID | 00848838036835 |
NIH Device Record Key | bb007a6b-9f9c-487f-aca7-989f27fafe9f |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | SENSITITRE YEASTONE SUSCEPTIBILITY PLATES |
Version Model Number | YO10 |
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 | true |
Device Combination Product | false |
Single Use | true |
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 | true |
OTC Over-The-Counter | false |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00848838036835 [Primary] |
NGZ | Susceptibility Test Plate, Antifungal |
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 |
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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 |