API® STREP

GUDID 03573026048440

API 20 Strep combines 20 biochemical tests to enable group or species ID of most streptococci and enterococci

BIOMERIEUX SA

Multiple Streptococcus bacterial species culture isolate identification IVD, kit
Primary Device ID03573026048440
NIH Device Record Key039d8d8d-b8c5-4ac4-a8cf-5748da4c502c
Commercial Distribution StatusIn Commercial Distribution
Brand NameAPI® STREP
Version Model Number20600
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
GS103573026048440 [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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