Antisera, Latex Agglutination, Cryptococcus Neoformans

Cryptococcus LTX Antigen Test 50TST/KT

Registry build 21.09.26
1manufacturer
2catalogue numbers in this listing

Who Else Makes It

Registered in Tianjin.

Chinese manufacturers registered for FDA product code GMD
Manufacturer City Province Registered as Device types
Genobio Pharmaceutical Co., Ltd. Tianjin Tianjin Manufacturer 1

Record

Regulatory record for Antisera, Latex Agglutination, Cryptococcus Neoformans
Listed by Remel, Inc., United States
FDA product code GMD
Device type Antisera, Latex Agglutination, Cryptococcus Neoformans
Device class Class 2
Regulation 21 CFR 866.3165
Establishment Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter
Record published 2016-09-24
Record revised 2022-11-28 (version 4)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Label carries lot or batch number, expiry date

Catalogue Numbers

Catalogue numbers for Antisera, Latex Agglutination, Cryptococcus Neoformans
Catalogue number Size Per pack Status
R30851502 In distribution
R30851501 50 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Immy Immuno-Mycologics, Inc. 6
Cryptococcal Antigen Latex Agglutination System (Calas) Meridian Bioscience, Inc. 1
Calas Pronase Meridian Bioscience, Inc. 1
Antisera, Latex Agglutination, Cryptococcus Neoformans Oxoid, Ltd. 1

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.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer