chromID® Strepto B agar

FDA UDI

Class I (US FDA UDI)

by Biomerieux , Inc.

Identity

Trade Name: chromID® Strepto B agar FDA UDI
Generic Name: Differential/selective agar culture medium IVD FDA UDI
Device Name: 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 FDA UDI
Model / Reference: chromID® Strepto B agar FDA UDI
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 FDA UDI

Identifiers

Primary DI / UDI-DI: 03573026598075 FDA UDI
510(k) Number: K163042 FDA UDI
FDA Product Code: PQZ FDA UDI
GMDN Term: Differential/selective agar culture medium IVD FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 866.2360 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Differential/selective agar culture medium IVD

chromID® Strepto B agar by Biomerieux , Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class I	Pending data

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Manufacturer

Manufacturer: Biomerieux , Inc.

Sources (1)

FDA UDI 200029d3-9eb1-43c5-806a-2c2f58a3f951 35 fields · synced Jun 8, 2026