Who else makes this device?

Name: Pras Campylobacter Selective Agar (Campy)
Brand: Pras Campylobacter Selective Agar (Campy)

Immunology & Microbiology › Microbiology DevicesCulture Media, Selective And Non-Differential

Pras Campylobacter Selective Agar (Campy)

AS-211 Campylobacter Selective Agar (CAMPY) is used for the selective isolation of Campylobacter jejuni subsp. jejuni from fecal or rectal swabs. Pre-reduced anaerobically sterilized…

Registry build 21.09.26

AS-211 Campylobacter Selective Agar (CAMPY) is used for the selective isolation of Campylobacter jejuni subsp. jejuni from fecal or rectal swabs. Pre-reduced anaerobically sterilized (PRAS). 100 x 15 mm agar plate. Transparent red. 1 plate per pack.

1manufacturer

1catalogue number

8510(k) clearances naming this product code

Who Else Makes It

Registered in Shandong.

Chinese manufacturers registered for FDA product code JSJ
Manufacturer	City	Province	Registered as	Device types
Jinan Babio Biotechnology Co., Ltd.	Jinan	Shandong	Manufacturer	25

Record

Regulatory record for Pras Campylobacter Selective Agar (Campy)
Listed by	Anaerobe Systems, United States
FDA product code	JSJ
Device type	Culture Media, Selective And Non-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 20 to 25 °C

Catalogue Numbers

Catalogue numbers for Pras Campylobacter Selective Agar (Campy)
Catalogue number	Size	Status
AS-211		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Remel	Remel, Inc.	132
Culture Media, Selective And Non-Differential	Hardy Diagnostics	85
Edge Biologicals Inc	Edge Biologicals, Inc.	17
HardyFlask™	Hardy Diagnostics	12
Alpha-Tec Systems	Alpha-Tec Systems, Inc.	11
Redipor	Analytichem USA, Inc.	9
AnaeroGRO	Hardy Diagnostics	3
BD BBL™ Campylobacter Agar with 5 Antimicrobics and 10% Sheep Blood	Becton, Dickinson AND Company	2
BD BBL™ XLD Agar	Becton, Dickinson AND Company	2
BD BBL™ Selenite-F Broth	Becton, Dickinson AND Company	2
BD BBL™ Campy CVA Agar	Becton, Dickinson AND Company	2
BD BBL™ Mycosel™ Agar Slants	Becton, Dickinson AND Company	2

Showing 12 of 92. All products under Culture Media, Selective And Non-Differential

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K841135	1984-03-26
K841140	1984-03-26
K841136	1984-03-26
K841139	1984-03-26
K841133	1984-03-23
K791578	1979-09-27
K781603	1978-10-10
K781602	1978-10-10

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.