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HardyCHROM

FDA UDI

Class I (US FDA UDI)

by Hardy Diagnostics

Identity

Trade Name
HardyCHROM FDA UDI
Generic Name
Differential/selective agar culture medium IVD FDA UDI
Device Name
HardyCHROM Group A Strep Agar (RSR) A chromogenic medium recommended for the selective cultivation and differential isolation of Group A Streptococcus (S. pyogenes) from specimens based on colony color. Some ingredients are very light sensitive. Store and incubate in the dark. FDA UDI
Model / Reference
GA337 FDA UDI
Description
HardyCHROM Group A Strep Agar (RSR) A chromogenic medium recommended for the selective cultivation and differential isolation of Group A Streptococcus (S. pyogenes) from specimens based on colony color. Some ingredients are very light sensitive. Store and incubate in the dark. FDA UDI

Identifiers

Catalog Number
GA337 FDA UDI
Primary DI / UDI-DI
00816576029105 FDA UDI
FDA Product Code
JSI 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
Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

HardyCHROM by Hardy Diagnostics — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Hardy Diagnostics

Sources (1)

  • FDA UDI f0d59c1f-f193-4498-8936-115768f19415 37 fields · synced Jun 6, 2026