Who else makes this device?

Immunology & Microbiology › Microbiology DevicesReagents, Clostridium Difficile Toxin

C. Diff Chek – 60

The C. DIFF CHEK™ - 60 test is an enzyme immunoassay for use as a screening test to detect Clostridium difficile antigen, glutamate dehydrogenase, in fecal specimens from persons suspected…

Registry build 21.09.26

The C. DIFF CHEK™ – 60 test is an enzyme immunoassay for use as a screening test to detect Clostridium difficile antigen, glutamate dehydrogenase, in fecal specimens from persons suspected of having C. difficile disease. The test does not distinguish toxigenic from nontoxigenic strains of C. difficile. With the use of additional tests that detect C. difficile toxins, this test is to be used as an aid in the diagnosis of C. difficile disease. As with other C. difficile tests, results should be considered in conjunction with patient history.

1manufacturer

5catalogue numbers in this listing

11510(k) clearances naming this product code

Who Else Makes It

Registered in Jiangsu.

Chinese manufacturers registered for FDA product code LLH
Manufacturer	City	Province	Registered as	Device types
Jiangsu Macro & Micro-Test MED-Tech Co., Ltd.	Nantong	Jiangsu	Manufacturer	11

Record

Regulatory record for C. Diff Chek – 60
Listed by	Techlab, Inc., United States
FDA product code	LLH
Device type	Reagents, Clostridium Difficile Toxin
Device class	Class 1
Regulation	21 CFR 866.2660
Establishment	Manufacturer
510(k)	K030992
Record published	2021-05-03
Record revised	2023-08-15 (version 2)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Single use	Yes
Prescription	Prescription only
Supplied as a kit	Yes
Label carries	lot or batch number, expiry date
Distribution end date	2021-07-26

Catalogue Numbers

Catalogue numbers for C. Diff Chek – 60
Catalogue number	Size	Status
TL5025		In distribution
30392B		In distribution
T5025B		In distribution
30392		In distribution
T5025		Withdrawn

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
C. Diff Quik Chek Complete	Techlab, Inc.	5
C. Difficile TOX A/B II	Techlab, Inc.	5
Xpert C. difficile	Cepheid	2
Trinity Biotech	Mardx Diagnostics, Inc.	2
TOX A/B Quik Chek	Techlab, Inc.	2
Remel	Remel, Inc.	2
C. Difficile TOX-B Test	Techlab, Inc.	2
Clostridium Difficile Glutamate Dehydrogenase(GDH) and Toxin A/B Detection Kit (	Jiangsu Macro & Micro-Test MED-Tech Co., Ltd.	2
Vidas® C. difficile Toxin A & B	bioMerieux, Inc.	1
ProSpecT™ Wash Buffer	Oxoid, Ltd.	1
Chorus Clia Clostridium Difficile A/B Toxins	Diesse Diagnostica Senese SPA	1
Prodesse	Hologic, Inc.	1

Showing 12 of 16. All products under Reagents, Clostridium Difficile Toxin

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K082499	2009-03-26
K050891	2005-07-25
K030992	2003-07-11
K030991	2003-07-11
K030404	2003-04-24
K003306	2000-11-22
K971182	1997-07-22
K935296	1994-04-26
K931129	1993-09-30
K923463	1993-02-01
K914902	1992-03-04

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.