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: BBE/LKV Biplate. Hardy Diagnostics AnaeroGRO™ Bacteroides Bile Esculin Agar is an enriched, selective, and differential medium recommended for the isolation and presumptive identification of obligately anaerobic gram-negative bacilli of the Bacteroides fragilis group and Bilophila spp. FDA UDI
Model / Reference: AG061 FDA UDI
Description: BBE/LKV Biplate. Hardy Diagnostics AnaeroGRO™ Bacteroides Bile Esculin Agar is an enriched, selective, and differential medium recommended for the isolation and presumptive identification of obligately anaerobic gram-negative bacilli of the Bacteroides fragilis group and Bilophila spp. FDA UDI

Identifiers

Catalog Number: AG061 FDA UDI
Primary DI / UDI-DI: 00816576024414 FDA UDI
FDA Product Code: JSI FDA UDI
JSJ 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
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

FDA UDI

Manufacturing Date

FDA UDI

Category: 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 890c9b3c-650d-434c-952a-1b6075cc1a37 36 fields · synced Jun 1, 2026