API® JAMES

GUDID 03573026099893

JAMES is a reagent associated to API® NH, API 20 ETM, API® 10 S, RapiD 20 ETM, API® 20 NE, RAPIDEC® ur, ID 32 E), rapid ID 32 A, rapid ID 32 E

BIOMERIEUX SA

Multiple Enterobacteriaceae species culture isolate identification IVD, reagent
Primary Device ID03573026099893
NIH Device Record Keyac294ece-8c3c-4000-9504-6311447cf986
Commercial Distribution StatusIn Commercial Distribution
Brand NameAPI® JAMES
Version Model Number70542
Company DUNS276816717
Company NameBIOMERIEUX SA
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS103573026099893 [Primary]

FDA Product Code

JTODISCS, STRIPS AND REAGENTS, MICROORGANISM DIFFERENTIATION

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-04-20
Device Publish Date2020-04-10

Devices Manufactured by BIOMERIEUX SA

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03573026118877 - chromID™ Salmonella Agar2024-01-31 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 v3.32023-11-22 VITEK® MS knowledge base v3.3
03573026073916 - Food Culture media2023-09-08 Selective isolation of Escherichia coli O157 :H7, and, for industrial applications only, enterohemorrhagic E. coli
03573026617622 - VIDAS® 3 SOFTWARE V1.42023-07-12 VIDAS 3 V1.4 Software

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