chromID® Strepto B agar

Primary DI
03573026598075
Brand
chromID® Strepto B agar
Company
BIOMERIEUX SA
Model
chromID® Strepto B agar
Device description
chromID® Strepto B agar is a selective chromogenic medium that is intended to aid in the qualitative determination of Group B Streptococcus (GBS) colonization in pregnant women
Published
2020-05-19
Public version status
New
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
PQZGBS culture media, selective and differential

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PQZGbs Culture Media, Selective And DifferentialMicrobiology1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K163042000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K163042000chromID Strepto B agarbioMerieux, Inc.2017-01-27PQZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03573026505684PackageGS12In Commercial Distribution
03573026598075PrimaryGS10
03573026598082Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03573026505684035730265056843573026505684
03573026598075035730265980753573026598075
03573026598082035730265980823573026598082

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
Lot or batch
true
Expiration date on label
true

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00816576024995N/AHARDY DIAGNOSTICSPQZ2020-05-18
00819398026499N/AHARDY DIAGNOSTICSPQZ2020-05-11
00819398026482N/AHARDY DIAGNOSTICSPQZ2020-05-11