FDA.reportPublic FDA data

API® M Medium

Primary DI
03573026588687
Brand
API® M Medium
Company
BIOMERIEUX SA
Model
API® M Medium
Device description
API M Medium allows the differentiation between motile and non-motile bacteria of the facultative aero-anaerobic group. It can be used to complement the API 20 E strip.
Published
2020-04-10
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
JSHCULTURE MEDIA, NON-SELECTIVE AND DIFFERENTIAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JSHCulture Media, Non-Selective And DifferentialMicrobiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03573026087364PackageGS110In Commercial Distribution
03573026588687PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03573026087364035730260873643573026087364
03573026588687035730265886873573026588687

GMDN Terms#

Term, Definition table
TermDefinition
Multiple Enterobacteriaceae species culture isolate identification IVD, reagentA substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the differentiation and/or identification of one or multiple species of oxidase negative, gram negative bacteria belonging to the Enterobacteriaceae family, that have been isolated by culture from a clinical specimen.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Regulatory Flags#

DUNS number
276816717
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

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B0744000160ASTUTE140 Electronic Quality Control (EQC) Device4000164000162016-08-12
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