Remel

FDA UDI

Class I (US FDA UDI)

by Remel, Inc.

Identity

Trade Name: REMEL FDA UDI
Generic Name: Microbiological transport medium IVD FDA UDI
Device Name: 10B Arginine Broth (1.8ml) 100/PK FDA UDI
Model / Reference: R20305 FDA UDI
Description: 10B Arginine Broth (1.8ml) 100/PK FDA UDI

Identifiers

Catalog Number: R20305 FDA UDI
Primary DI / UDI-DI: 00848838021893 FDA UDI
510(k) Number: K965152 FDA UDI
FDA Product Code: JSM FDA UDI
GMDN Term: Microbiological 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

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: Microbiological transport medium IVD

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

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Cleared under the same submission

K965152 also covers:

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: Remel, Inc.

Sources (1)

FDA UDI fb72af67-ec95-4ad0-bba3-5581cd74b98d 35 fields · synced May 30, 2026