Who else makes this device?

Name: C. Difficile TOX-B Test
Brand: C. Difficile TOX-B Test

Immunology & Microbiology › Microbiology DevicesReagents, Clostridium Difficile Toxin

C. Difficile TOX-B Test

The C. DIFFICILE TOX-B TEST is intended for use in conjunction with the tissue culture cytotoxicity assay for the detection of C. difficile toxin B in patient specimens. The test is to be…

Registry build 21.09.26

The C. DIFFICILE TOX-B TEST is intended for use in conjunction with the tissue culture cytotoxicity assay for the detection of C. difficile toxin B in patient specimens. The test is to be used as an aid in the diagnosis of C. difficile disease and results should be considered in conjunction with patient history.

1manufacturer

2catalogue 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. Difficile TOX-B Test
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
Record published	2020-01-24
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	2021-05-04

Catalogue Numbers

Catalogue numbers for C. Difficile TOX-B Test
Catalogue number	Size	Status
T5003		In distribution
30399U		Withdrawn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. Diff Chek – 60	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
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.