Primary Device ID | 03573026141998 |
NIH Device Record Key | 34eb61be-0d72-4729-afc1-146d63fdf580 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | API® ZYM B |
Version Model Number | 70493 |
Company DUNS | 276816717 |
Company Name | BIOMERIEUX SA |
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 | true |
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 | true |
OTC Over-The-Counter | false |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Device Issuing Agency | Device ID |
---|---|
GS1 | 03573026141998 [Primary] |
JTO | DISCS, STRIPS AND REAGENTS, MICROORGANISM DIFFERENTIATION |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2020-04-20 |
Device Publish Date | 2020-04-10 |
03573026617851 - VITEK®MS | 2024-03-18 VITEK MS ready to use reagent for calibration and fine tuning of the VITEK MS instrument |
03573026635046 - EMAG® SOFTWARE V1.4 | 2024-02-12 EMAG software (virtual) version 1.4 also called SP4 |
03573026118877 - chromID™ Salmonella Agar | 2024-01-31 Chromogenic medium for the selective isolation and differentiation of the genus Salmonella |
03573026624545 - ETEST® Tobramycin (TM) | 2023-12-28 ETEST® is a manual, quantitative technique for determination of antimicrobial susceptibility of non-fastidious Gram-negative an |
03573026613808 - ETEST® Sulbactam/Durlobactam (SUD) | 2023-12-26 ETEST® is a manual, quantitative technique for determination of antimicrobial susceptibility of non-fastidious Gram-negative an |
03573026628154 - VITEK® MS knowledge base v3.3 | 2023-11-22 VITEK® MS knowledge base v3.3 |
03573026073916 - Food Culture media | 2023-09-08 Selective isolation of Escherichia coli O157 :H7, and, for industrial applications only, enterohemorrhagic E. coli |
03573026617622 - VIDAS® 3 SOFTWARE V1.4 | 2023-07-12 VIDAS 3 V1.4 Software |