Who else makes this device?

Name: Pras Cycloserine Cefoxitin Mannitol Broth w/ Taurocholate & Lysozyme (Ccmb-TAL)
Brand: Pras Cycloserine Cefoxitin Mannitol Broth w/ Taurocholate & Lysozyme (Ccmb-TAL)

Immunology & Microbiology › Microbiology DevicesCulture Media, Selective And Differential

Pras Cycloserine Cefoxitin Mannitol Broth W/ Taurocholate & Lysozyme (Ccmb-TAL)

AS-8216 Cycloserine Cefoxitin Mannitol Broth with Taurocholate and Lysozyme (CCMB-TAL) is an enriched, selective, and differential broth media used for the isolation and presumptive…

Registry build 21.09.26

AS-8216 Cycloserine Cefoxitin Mannitol Broth with Taurocholate and Lysozyme (CCMB-TAL) is an enriched, selective, and differential broth media used for the isolation and presumptive identification of Clostridioides difficile. Pre-reduced anaerobically sterilized (PRAS). 5 mL fill volume. 16 x 100 mm hungate-capped tube. Transparent red liquid. 10 tubes per pack.

1manufacturer

1catalogue number

12510(k) clearances naming this product 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 Pras Cycloserine Cefoxitin Mannitol Broth w/ Taurocholate & Lysozyme (Ccmb-TAL)
Listed by	Anaerobe Systems, United States
FDA product code	JSI
Device type	Culture Media, Selective And Differential
Device class	Class 1
Regulation	21 CFR 866.2360
Establishment	Complaint-file establishment, Manufacturer
Premarket notification	Exempt
Record published	2020-05-01

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Single use	Yes
Label carries	lot or batch number, expiry date
Storage	Storage environment temperature 2 to 8 °C

Catalogue Numbers

Catalogue numbers for Pras Cycloserine Cefoxitin Mannitol Broth w/ Taurocholate & Lysozyme (Ccmb-TAL)
Catalogue number	Size	Per pack	Status
AS-8216		10	In distribution

Same Product Code

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510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K841218	1984-04-05
K841142	1984-04-05
K841222	1984-04-04
K841141	1984-03-26
K841134	1984-03-26
K841131	1984-03-23
K841129	1984-03-23
K841132	1984-03-23
K791563	1979-09-17
K791579	1979-09-17
K790624	1979-04-23
K790628	1979-04-23

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.