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Remel

FDA UDI

Class I (US FDA UDI)

by Remel, Inc.

Identity

Trade Name
Remel FDA UDI
Generic Name
Clostridium difficile antigen IVD, kit, rapid ICT, clinical FDA UDI
Device Name
Xpect C. diff Toxin A/B KT/40TST FDA UDI
Model / Reference
R24640 FDA UDI
Description
Xpect C. diff Toxin A/B KT/40TST FDA UDI

Identifiers

Primary DI / UDI-DI
00848838068416 FDA UDI
510(k) Number
K041951 FDA UDI
FDA Product Code
LLH FDA UDI
GMDN Term
Clostridium difficile antigen IVD, kit, rapid ICT, clinical FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
866.2660 FDA UDI
Commercial Distribution
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

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Clostridium difficile antigen IVD, kit, rapid ICT, clinical

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

Similar devices

Also classified as Clostridium difficile antigen IVD, kit, rapid ICT, clinical.

Cleared under the same submission

K041951 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Remel, Inc.

Sources (1)

  • FDA UDI 476fa4ef-40e7-46ad-9ffa-cd63ec0cece5 35 fields · synced May 30, 2026