Edge Biologicals Inc

Brain Heart Infusion Agar W/ Gentamicin

Registry build 21.09.26
1manufacturer
17catalogue numbers in this listing

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 Edge Biologicals Inc
Listed by Edge Biologicals, Inc., United States
FDA product code JSJ
Device type Culture Media, Selective And Non-Differential
Device class Class 1
Regulation 21 CFR 866.2360
Premarket notification Exempt
Record published 2025-04-16
Record revised 2023-08-18 (version 2)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Supplied sterile Yes
Single use Yes
Label carries lot or batch number, expiry date, manufacturing date, serial number
Storage Storage environment temperature 2 to 8 °C
Distribution end date 2025-04-21
UDI direct marking Exempt

Catalogue Numbers

Catalogue numbers for Edge Biologicals Inc
Catalogue number Size Per pack Status
4P021 In distribution
3P276 In distribution
4P022 10 Withdrawn
T0631 10 Withdrawn
4P230 10 Withdrawn
4P256 10 Withdrawn
4P159 10 Withdrawn
T0160 10 Withdrawn
3P395 10 Withdrawn
T0800 10 Withdrawn
3P275 10 Withdrawn
4P330 10 Withdrawn
T0004 10 Withdrawn
1R009 10 Withdrawn
4M021 10 Withdrawn
3P390 10 Withdrawn
4P151 10 Withdrawn

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
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
BD BBL™ Middlebrook and Cohn 7H10 Agar Slants Becton, Dickinson AND Company 2

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