HardyCHROM

Blood Agar 5% / HardyCHROM™ UTI, 15x100mm Biplate, 10ml/10ml. Hardy Diagnostics Blood Agar products are recommended for use as general purpose growth media for the isolation, cultivation,…

Registry build 21.09.26

Blood Agar 5% / HardyCHROM™ UTI, 15x100mm Biplate, 10ml/10ml. Hardy Diagnostics Blood Agar products are recommended for use as general purpose growth media for the isolation, cultivation, and differentiation of a wide variety of microorganisms. HardyCHROM™ UTI is a non-selective chromogenic medium recommended for the cultivation, differentiation and enumeration of urinary tract pathogens based on colony color and morphology.

2manufacturers in China registered for this device type
3catalogue numbers in this listing

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 HardyCHROM
Listed by Hardy Diagnostics, United States
FDA product code JSH
Device type Culture Media, Non-Selective And Differential
Device class Class 1
Regulation 21 CFR 866.2320
Establishment Contract manufacturer, Remanufacturer, Specification developer, Repacker / relabeller, Manufacturer, Exporter
Premarket notification Exempt
Record published 2020-05-20
Record revised 2024-08-27 (version 3)

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
Distribution end date 2022-02-28

Catalogue Numbers

Catalogue numbers for HardyCHROM
Catalogue number Size Per pack Status
G313 10 In distribution
J119 10 In distribution
G315 10 Withdrawn

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
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
BD BBL™ TSI Agar Slants Becton, Dickinson AND Company 2

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

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