Who else makes this device?

Name: Pras CDC Anaerobic Blood Agar (CDC)
Brand: Pras CDC Anaerobic Blood Agar (CDC)

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

Pras CDC Anaerobic Blood Agar (CDC)

AS-646 CDC Anaerobic Blood Agar (CDC) is an enriched and differential media used for the growth and partial identification of obligate anaerobes. Pre-reduced anaerobically sterilized…

Registry build 21.09.26

AS-646 CDC Anaerobic Blood Agar (CDC) is an enriched and differential media used for the growth and partial identification of obligate anaerobes. Pre-reduced anaerobically sterilized (PRAS). 100 x 15 mm agar plate. Opaque burgundy red. 4 plates per pack.

2manufacturers in China registered for this device type

1catalogue number

3510(k) clearances naming this product code

Who Else Makes It

Concentrated in Shandong (1), Shaanxi (1).

Chinese manufacturers registered for FDA product code JSH
Manufacturer	City	Province	Registered as	Device types
Jinan Babio Biotechnology Co., Ltd.	Jinan	Shandong	Manufacturer	25
Xian Tianlong Science AND Technology Co., Ltd.	Xi’An	Shaanxi	Manufacturer	8

Record

Regulatory record for Pras CDC Anaerobic Blood Agar (CDC)
Listed by	Anaerobe Systems, United States
FDA product code	JSH
Device type	Culture Media, Non-Selective And Differential
Device class	Class 1
Regulation	21 CFR 866.2320
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 CDC Anaerobic Blood Agar (CDC)
Catalogue number	Size	Per pack	Status
AS-646		4	In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Remel	Remel, Inc.	67
Culture Media, Non-Selective And Differential	Hardy Diagnostics	63
Edge Biologicals Inc	Edge Biologicals, Inc.	29
Redipor	Analytichem USA, Inc.	20
Cystine Lactose Electrolyte Deficient (Cled) Agar	Neogen Technologies, Inc.	5
Select	BIO-RAD	3
Spectra	Remel, Inc.	3
Pras Chopped Meat Medium w/ Glucose (CMG)	Anaerobe Systems	3
HardyCHROM	Hardy Diagnostics	3
Pras Chopped Meat Medium (CM)	Anaerobe Systems	3
Pras Chopped Meat Medium w/ Carbohydrates (CMC)	Anaerobe Systems	3
BD BBL™ Urea Agar Slants	Becton, Dickinson AND Company	2

Showing 12 of 84. All products under Culture Media, Non-Selective And Differential

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K790627	1979-05-01
K790618	1979-04-23
K790623	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.