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Remel

FDA UDI

Class I (US FDA UDI)

by Remel, Inc.

Identity

Trade Name
REMEL FDA UDI
Generic Name
General-microorganism antimicrobial susceptibility culture medium IVD FDA UDI
Device Name
MH Agar w/1% Hgb,1% GCHI (150mm) 10/PK FDA UDI
Model / Reference
R04059 FDA UDI
Description
MH Agar w/1% Hgb,1% GCHI (150mm) 10/PK FDA UDI

Identifiers

Catalog Number
R04059 FDA UDI
Primary DI / UDI-DI
00848838004537 FDA UDI
FDA Product Code
JSG FDA UDI
GMDN Term
General-microorganism antimicrobial susceptibility culture medium IVD FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
866.2300 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

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

Category: General-microorganism antimicrobial susceptibility culture medium IVD

Remel by Remel, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as General-microorganism antimicrobial susceptibility culture medium IVD.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Remel, Inc.

Sources (1)

  • FDA UDI 9e45ff72-8eb4-4c97-911b-f1cbe2257fc0 34 fields · synced May 31, 2026