FDA.reportPublic FDA data

CHROMID® S. aureus Elite agar

Primary DI
03573026600440
Brand
CHROMID® S. aureus Elite agar
Company
BIOMERIEUX SA
Model
CHROMID® S. aureus Elite agar
Device description
Selective isolation and direct identification of Staphylococcus aureus
Published
2020-05-19
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
JSICULTURE MEDIA, SELECTIVE AND DIFFERENTIAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JSICulture Media, Selective And DifferentialMicrobiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03573026494445PackageGS12In Commercial Distribution
03573026600440PrimaryGS10
03573026600457Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03573026494445035730264944453573026494445
03573026600440035730266004403573026600440
03573026600457035730266004573573026600457

GMDN Terms#

Term, Definition table
TermDefinition
Differential/selective agar culture medium IVDAn agar culture medium intended to be used to promote the selective growth of a microbial species with specific characteristics (e.g., antibiotic resistance, ability to utilize, synthesize specific metabolites) and/or distinguish between microbial species growing on the same medium by appearance (e.g., colour, shape, growth pattern). It typically contains substances to inhibit the growth of commensal or contaminating microorganisms (e.g., antimicrobials, dyes, salts) and/or dyes or chemical indicators for differentiation.

Storage And Handling#

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

Regulatory Flags#

DUNS number
276816717
Device count
10
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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03573026548674ETEST® Ampicillin/sulbactam (2/1) (AB)ETEST® Ampicillin/sulbactam (2/1) (AB)2016-11-18
03573026549046ETEST® Tetracycline (TC)ETEST® Tetracycline (TC)2016-11-18
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