Who else makes this device?

Name: Premier Toxins A and B
Brand: Premier Toxins A and B

Immunology & Microbiology › Microbiology DevicesReagents, Clostridium Difficile Toxin

Premier Toxins a and B

Premier Toxins A&B is a qualitative enzyme immunoassay for the detection of Clostridium difficile toxin A and toxin B in stool from patients with antibiotic-associated diarrhea. Premier…

Registry build 21.09.26

Premier Toxins A&B is a qualitative enzyme immunoassay for the detection of Clostridium difficile toxin A and toxin B in stool from patients with antibiotic-associated diarrhea. Premier Toxins A&B is intended for use as an aid in the diagnosis of C. difficile associated disease (CDAD).

1manufacturer

1catalogue number

1510(k) clearance

2recalls on this 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 Premier Toxins A and B
Listed by	Meridian Bioscience, Inc., United States
FDA product code	LLH
Device type	Reagents, Clostridium Difficile Toxin
Device class	Class 1
Regulation	21 CFR 866.2660
Establishment	Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer
510(k)	K993914
Record published	2020-09-01

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
Storage	Storage environment temperature 2 to 8 °C

Catalogue Numbers

Catalogue numbers for Premier Toxins A and B
Catalogue number	Size	Status
616096		In distribution

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
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

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
K041003	2004-08-20

Recalls Naming This Product

1 recall names this product by its own identifier, the 510(k) it is cleared under.

Recalls naming the identifiers of Premier Toxins A and B
Recalled by	Identified by	Initiated	FDA class	Root cause	Reason	Quantity	Closed
Meridian Bioscience, Inc.	510(k) number	2003-09-23	Not classified	Other	The kits were packaged with incorrect dispensing pipettes.	2030 kits	2004-03-29

Recalls

The FDA has not published a severity grade for these. Volume alone is not a quality signal: a manufacturer that ships more recalls more.

Recalls referencing this product code
Initiated	FDA class	Root cause	Reason	Quantity	Closed
2006-06-02	Not classified	Other	The product may produce non-specific reactions with negative specimens and/or the negative control reagent. These non-specific interactions may result in increased invalid test rates and/or positivity rates.	704	2012-02-16

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.