Who else makes this device?

Name: Salmonella H z Agglutinating Sera
Brand: Salmonella H z Agglutinating Sera

Immunology & Microbiology › Serological ReagentsAntisera, All Groups, Salmonella Spp.

Salmonella H Z Agglutinating Sera

Catalogue number R30162401, listed by Remel Europe Ltd, United Kingdom, under Antisera, All Groups, Salmonella Spp. 1 manufacturer in China is registered for this product code.

Registry build 21.09.26

1manufacturer

1catalogue number

1recall

Who Else Makes It

Registered in Beijing.

Chinese manufacturers registered for FDA product code GRM
Manufacturer	City	Province	Registered as	Device types
Beijing Genesee Biotech, Inc.	Beijing	Beijing	Manufacturer	4

Record

Regulatory record for Salmonella H z Agglutinating Sera
Listed by	Remel Europe Ltd, United Kingdom
FDA product code	GRM
Device type	Antisera, All Groups, Salmonella Spp.
Device class	Class 2
Regulation	21 CFR 866.3550
Establishment	Contract manufacturer, Specification developer, Manufacturer
Premarket notification	Exempt
Record published	2021-07-21

Specifications

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

Catalogue Numbers

Catalogue numbers for Salmonella H z Agglutinating Sera
Catalogue number	Size	Status
R30162401		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Antisera, All Groups, Salmonella Spp.	Remel Europe Ltd	69
Antisera, All Groups, Salmonella Spp.	Hardy Diagnostics	59
Mast Assure Antisera	Mast Group Ltd.	31
Mast Assure	Mast Group Ltd.	15
Monovalent Flagella Salmonella Antisera – Factor z29	pro-lab incorporated	10
Monovalent Flagella Salmonella Antisera – Factor enx	pro-lab incorporated	3
Rapid Polyvalent Salmonella Diagnostic Sera RSD 2	pro-lab incorporated	3
BD Difco™ Salmonella O Antiserum Group B Factors 1, 4, 12, 27	Becton, Dickinson AND Company	2
Salmonella Sero-Quick Group Kit	SSI Diagnostica A/S	2
Monovalent Flagella Salmonella Antisera – Factors l, v	pro-lab incorporated	2
Polyvalent Flagella Salmonella Antisera – H Phase 1 & 2	pro-lab incorporated	2
BD Difco™ Salmonella H Antiserum Single Factor z23	Becton, Dickinson AND Company	2

Showing 12 of 404. All products under Antisera, All Groups, Salmonella Spp.

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
2026-03-25	Class II	Under Investigation by firm	Affected lots are not performing to IFU criteria showing cross reactions with 2-0 within 60 seconds. Cross-reactivity may result in the misidentification of a Salmonella 9-O serotype as a 2-O serotype.	117 US; 950 OUS

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.