ID 32 STAPH

GUDID 03573026066499

ID 32 STAPH is a standardized system for the identification of the genera Staphylococcus, Micrococcus and related genera, Rothia and Aerococcus

BIOMERIEUX SA

Multiple aerobic gram positive bacteria species culture isolate identification IVD, kit
Primary Device ID03573026066499
NIH Device Record Keyc55e49bb-f364-4e5e-a14c-80e8e608e6ad
Commercial Distribution StatusIn Commercial Distribution
Brand NameID 32 STAPH
Version Model NumberID 32 STAPH
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 Kitfalse
Device Combination Productfalse
Single Usetrue
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
GS103573026066499 [Package]
Contains: 03573026588601
Package: [25 Units]
In Commercial Distribution
GS103573026588601 [Primary]

FDA Product Code

JWXKIT, SCREENING, STAPHYLOCOCCUS AUREUS

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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