AnaeroGRO

FDA UDI

Class I (US FDA UDI)

by Hardy Diagnostics

Identity

Trade Name: AnaeroGRO FDA UDI
Generic Name: Multiple formulation agar culture medium IVD FDA UDI
Device Name: DuoPak B, BRU with Hemin and Vitamin K, Monoplate; BBE/PEA, Biplate. Hardy Diagnostics AnaeroGRO™ Brucella Agar with Hemin and Vitamin K is recommended for use in the primary isolation, quantitation, and partial identification of obligately anaerobic microorganisms from clinical specimens. This non-selective medium is also suitable for the growth of aerobic and microaerophilic bacteria when incubated under the appropriate conditions. FDA UDI
Model / Reference: AG312 FDA UDI
Description: DuoPak B, BRU with Hemin and Vitamin K, Monoplate; BBE/PEA, Biplate. Hardy Diagnostics AnaeroGRO™ Brucella Agar with Hemin and Vitamin K is recommended for use in the primary isolation, quantitation, and partial identification of obligately anaerobic microorganisms from clinical specimens. This non-selective medium is also suitable for the growth of aerobic and microaerophilic bacteria when incubated under the appropriate conditions. FDA UDI

Identifiers

Catalog Number: AG312 FDA UDI
Primary DI / UDI-DI: 00816576024476 FDA UDI
FDA Product Code: JSI FDA UDI
JSJ FDA UDI
KZI FDA UDI
GMDN Term: Multiple formulation agar culture medium IVD FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 866.2360 FDA UDI
866.2330 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

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

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Manufacturing Date

FDA UDI

Category: Enriched agar culture medium IVD Multiple formulation agar culture medium IVD

AnaeroGRO by Hardy Diagnostics — 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: Hardy Diagnostics

Sources (1)

FDA UDI 10a5729d-85f7-439b-9c34-1fc558fe1d01 36 fields · synced May 30, 2026