C&S Medium

Para-Fix C&S Medium preserves fecal specimens for culture of intestinal enteric bacteria during transport. It is a nonnutritive, buffered, isotonic solution designed to maintain the…

Registry build 21.09.26

Para-Fix C&S Medium preserves fecal specimens for culture of intestinal enteric bacteria during transport. It is a nonnutritive, buffered, isotonic solution designed to maintain the organisms rather than support their overgrowth.

Agar and sodium thioglycolate maintain low oxygen tension for anaerobic species. A phenol-red indicator turns yellow when the solution becomes acidic and conditions are less suitable for recovering the intended organisms.

Listed Item

A modified Cary and Blair Medium intended to be used for the preservation and transport of gram negative and anaerobic microorganisms from a clinical specimen. The tubes are supplied with red caps and a spork for specimen handling.

Collection Container

Each 30 mL vial holds 15 mL of medium and has an integrated specimen-collection spoon or spork. Kits may include instructions and a resealable bag. The medium is intended to maintain bacteria for up to 96 hours before culture processing.

11manufacturers in China registered for this device type
5catalogue numbers in this listing
2510(k) clearances naming this product code

Who Else Makes It

Concentrated in Zhejiang (4), Jiangsu (3), Shandong (1).

Chinese manufacturers registered for FDA product code JSM
Manufacturer City Province Registered as Device types
Hangzhou AllTest Biotech Co., Ltd. Hangzhou Zhejiang Contract manufacturer 48
Citotest Labware Manufacturing Co., Ltd. Haimen Jiangsu Repacker / relabeller 46
Citotest Scientific Co., Ltd. Nanjing Jiangsu Repacker / relabeller 46
Zhejiang Gongdong Medical Technology Co., Ltd. Taizhou Zhejiang Contract manufacturer 40
Jinan Babio Biotechnology Co., Ltd. Jinan Shandong Manufacturer 25
Bioteke Corporation (Wuxi) Co., Ltd. Wuxi Jiangsu Manufacturer 21
Hangzhou Best Valley Medical Technology Co., Ltd. Hangzhou Zhejiang Exporter 20
Changsha Renji Medical Equipment Co., Ltd. Changsha Hunan Manufacturer 15
Sterigenics Shanghai E Beam Ltd. Shanghai Shanghai Contract manufacturer 14
Huachenyang(Shenzhen)Technology Co., Ltd. Shenzhen Guangdong Manufacturer 7
Hangzhou Genesis Biodetection & Biocontrol Co., Ltd. Hangzhou Zhejiang Contract manufacturer 5

Record

Regulatory record for C&S Medium
Listed by Medical Chemical Corporation, United States
FDA product code JSM
Device type Culture Media, Non-Propagating Transport
Device class Class 1
Regulation 21 CFR 866.2390
Establishment Contract manufacturer, Repacker / relabeller, Manufacturer
510(k) K150887
Record published 2020-08-31

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Single use Yes
Prescription Prescription only
Storage Storage environment temperature 15 to 30 °C
Packaging Case of 4

Catalogue Numbers

Catalogue numbers for C&S Medium
Catalogue number Size Per pack Status
2805-05_ORANGE 25 In distribution
2805-05_RED_SP 25 In distribution
2805-05 25 In distribution
2805-05-10_PACK 10 In distribution
2805-05-WB 100 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
BioSci Shenzhen Dakewe BIO-Engineering Co., Ltd. 27
UTM® Copan Italia 18
Bioer Viral Transport Medium Hangzhou Bioer Technology Co., Ltd. 15
Fisherbrand Fisher Scientific Company L.L.C. 13
TransPorter® Copan Italia 13
UTM-RT Copan Italia 12
MicroTest M4RT Remel, Inc. 12
BBL™ CultureSwab™ Copan Italia 11
iClean Huachenyang(Shenzhen)Technology Co., Ltd. 11
Gongdong Zhejiang Gongdong Medical Technology Co., Ltd. 11
Transystem™ Copan Italia 10
MicroTest M6 Remel, Inc. 9

Showing 12 of 98. All products under Culture Media, Non-Propagating Transport

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance Decision date
K150887 2015-05-29
K141506 2015-02-25

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.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer