AnaeroGRO

FDA UDI

Class I (US FDA UDI)

by Hardy Diagnostics

Identity

Trade Name: AnaeroGRO FDA UDI
Generic Name: Anaerobic transport medium IVD FDA UDI
Device Name: Anaerobic Transport Medium, 15x103mm Tube with Hungate Septum Cap and No Swabs, 7ml. Hardy Diagnostics AnaeroGRO™ Anaerobic Transport Medium is recommended for use in maintaining the viability of obligate anaerobic microorganisms, as well as aerobic and facultatively anaerobic bacteria, during transport. Starswab™ Anaerobic Transport Systems are enclosed, self-contained, ready-to-use, sterile surgery packs, available with or without swabs, for maintaining anaerobic transport of clinical specimens. FDA UDI
Model / Reference: AG25H FDA UDI
Description: Anaerobic Transport Medium, 15x103mm Tube with Hungate Septum Cap and No Swabs, 7ml. Hardy Diagnostics AnaeroGRO™ Anaerobic Transport Medium is recommended for use in maintaining the viability of obligate anaerobic microorganisms, as well as aerobic and facultatively anaerobic bacteria, during transport. Starswab™ Anaerobic Transport Systems are enclosed, self-contained, ready-to-use, sterile surgery packs, available with or without swabs, for maintaining anaerobic transport of clinical specimens. FDA UDI

Identifiers

Catalog Number: AG25H FDA UDI
Primary DI / UDI-DI: 00819398026338 FDA UDI
510(k) Number: K944847 FDA UDI
FDA Product Code: JSL FDA UDI
GMDN Term: Anaerobic transport medium IVD FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 866.2390 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

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Anaerobic transport 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 853043d4-d633-4911-b584-b9f512064f51 37 fields · synced May 31, 2026