Who else makes this device?

Name: Premier Cryptococcal Antigen
Brand: Premier Cryptococcal Antigen

Immunology & Microbiology › Serological ReagentsAntigen, Elisa, Cryptococcus

Premier Cryptococcal Antigen

The PREMIERCryptococcal Antigen enzyme immunoassay (EIA) is a screening or a semi-quantitative test system for the detection of capsular polysaccharide antigens of Cryptococcus neoformans…

Registry build 21.09.26

The PREMIERCryptococcal Antigen enzyme immunoassay (EIA) is a screening or a semi-quantitative test system for the detection of capsular polysaccharide antigens of Cryptococcus neoformans in serum and cerebrospinal fluid (CSF).

1manufacturer

1catalogue number

1recall

Who Else Makes It

Registered in Tianjin.

Chinese manufacturers registered for FDA product code MDU
Manufacturer	City	Province	Registered as	Device types
Dynamiker Biotechnology (Tianjin) Co., Ltd.	Tianjin	Tianjin	Manufacturer	3

Record

Regulatory record for Premier Cryptococcal Antigen
Listed by	Meridian Bioscience, Inc., United States
FDA product code	MDU
Device type	Antigen, Elisa, Cryptococcus
Device class	Class 2
Regulation	21 CFR 866.3165
Establishment	Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer
Record published	2016-09-23
Record revised	2018-03-29 (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
Storage	Handling environment temperature 2 to 8 °C

Catalogue Numbers

Catalogue numbers for Premier Cryptococcal Antigen
Catalogue number	Size	Status
602096		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Immy	Immuno-Mycologics, Inc.	1

Recalls

1 of these is Class II. Class II means a temporary or reversible health consequence. 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
2018-12-17	Class II	Unknown/Undetermined by firm	An enzyme reagent included in the kit is not maintaining stability through claimed product expiration, resulting in the potential for false negative results when tested with patient specimens and the positive control.	184	2020-04-30

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.