API® BCP

GUDID 03573026099855

BCP is a reagent associated to API 20 A® (20 300) & rapid ID 32 E (32 700)

BIOMERIEUX SA

Multiple anaerobic bacteria species culture isolate identification IVD, reagent Multiple anaerobic bacteria species culture isolate identification IVD, reagent Multiple anaerobic bacteria species culture isolate identification IVD, reagent Multiple anaerobic bacteria species culture isolate identification IVD, reagent Multiple anaerobic bacteria species culture isolate identification IVD, reagent Multiple anaerobic bacteria species culture isolate identification IVD, reagent Multiple anaerobic bacteria species culture isolate identification IVD, reagent Multiple anaerobic bacteria species culture isolate identification IVD, reagent Multiple anaerobic bacteria species culture isolate identification IVD, reagent Multiple anaerobic bacteria species culture isolate identification IVD, reagent Multiple anaerobic bacteria species culture isolate identification IVD, reagent Multiple anaerobic bacteria species culture isolate identification IVD, reagent Multiple anaerobic bacteria species culture isolate identification IVD, reagent Multiple anaerobic bacteria species culture isolate identification IVD, reagent Multiple anaerobic bacteria species culture isolate identification IVD, reagent Multiple anaerobic bacteria species culture isolate identification IVD, reagent Multiple anaerobic bacteria species culture isolate identification IVD, reagent Multiple anaerobic bacteria species culture isolate identification IVD, reagent Multiple anaerobic bacteria species culture isolate identification IVD, reagent
Primary Device ID03573026099855
NIH Device Record Key16db6e9d-03f0-4cec-92f8-d02c75187f4d
Commercial Distribution StatusIn Commercial Distribution
Brand NameAPI® BCP
Version Model Number70510
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 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS103573026099855 [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

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