Who else makes this device?

Name: Food Culture media
Brand: Food Culture media

Immunology & Microbiology › Microbiology DevicesCulture Media, Selective And Differential

Food Culture Media

Selective isolation of Escherichia coli O157 :H7, and, for industrial applications only, enterohemorrhagic E. coli

Registry build 21.09.26

1manufacturer

1catalogue number

11510(k) clearances naming this product code

2recalls on this code

Who Else Makes It

Registered in Guangdong.

Chinese manufacturers registered for FDA product code JSI
Manufacturer	City	Province	Registered as	Device types
Guangdong Huankai Biology SCI.&Tech.co., Ltd.	Zhaoqing	Guangdong	Manufacturer	2

Record

Regulatory record for Food Culture media
Listed by	bioMerieux, Inc., United States
FDA product code	JSI
Device type	Culture Media, Selective And Differential
Device class	Class 1
Regulation	21 CFR 866.2360
Establishment	Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter
Premarket notification	Exempt
Record published	2019-08-22
Record revised	2023-09-11 (version 3)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Single use	Yes
Prescription	Prescription only
Label carries	lot or batch number, expiry date
Storage	Storage environment temperature 2 to 8 °C
Packaging	Pack of 6
Distribution end date	2023-08-08

Catalogue Numbers

Catalogue numbers for Food Culture media
Catalogue number	Size	Status
Food Culture media		Withdrawn

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Remel	Remel, Inc.	137
Culture Media, Selective And Differential	Hardy Diagnostics	102
Edge Biologicals Inc	Edge Biologicals, Inc.	40
Redipor	Analytichem USA, Inc.	27
HardyCHROM	Hardy Diagnostics	11
AnaeroGRO	Hardy Diagnostics	5
BD BBL™ Sabouraud Dextrose Agar Slants	Becton, Dickinson AND Company	2
Macconkey Agar (Without Salt)	Oxoid, Ltd.	2
Pras Laked Brucella Blood Agar w/ Kanamycin & Vancomycin (LKV)	Anaerobe Systems	2
BD BBL™ Bile Esculin Agar Slants	Becton, Dickinson AND Company	2
BD BBL™ MacConkey II Agar with Sorbitol	Becton, Dickinson AND Company	2
BD BBL™ Hektoen Enteric Agar	Becton, Dickinson AND Company	2

Showing 12 of 97. All products under Culture Media, Selective And Differential

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K871094	1987-04-03
K871088	1987-04-03
K844515	1985-01-07
K844535	1985-01-05
K830082	1983-02-10
K830065	1983-02-10
K830072	1983-02-09
K830079	1983-02-09
K830070	1983-02-09
K830064	1983-02-09
K830071	1983-02-09

Recalls

2 of these are 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
2022-11-09	Class II	Storage	As the temperature and time out of range was exceeded, product performances cannot be guaranteed	10 units
2022-11-09	Class II	Storage	As the temperature and time out of range was exceeded, product performances cannot be guaranteed	1 unit

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.