HardyFlask™

Middlebrook 7H10 Agar, 12ml fill, 50ml plastic HardyFlask™, order by the package of 20 Middlebrook 7H10 Agar is recommended for use in qualitative procedures for the isolation and…

Registry build 21.09.26

Middlebrook 7H10 Agar, 12ml fill, 50ml plastic HardyFlask™, order by the package of 20 Middlebrook 7H10 Agar is recommended for use in qualitative procedures for the isolation and cultivation of Mycobacterium species.

1manufacturer
3catalogue numbers in this listing

Who Else Makes It

Registered in Shandong.

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

Record

Regulatory record for HardyFlask™
Listed by Hardy Diagnostics, United States
FDA product code KZI
Device type Culture Media, Enriched
Device class Class 1
Regulation 21 CFR 866.2330
Establishment Contract manufacturer, Remanufacturer, Specification developer, Repacker / relabeller, Manufacturer, Exporter
Premarket notification Exempt
Record published 2020-06-08
Record revised 2026-01-30 (version 2)

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 2026-01-29

Catalogue Numbers

Catalogue numbers for HardyFlask™
Catalogue number Size Per pack Status
X28 20 In distribution
X25 20 In distribution
X26 20 Withdrawn

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Culture Media, Enriched Hardy Diagnostics 55
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Pras Oral Treponeme Enrichment Broth (Oteb) Anaerobe Systems 3
Redipor Analytichem USA, Inc. 3
BD BBL™ Lowenstein-Jensen Medium Slants Becton, Dickinson AND Company 2
Pras BRU PEA BBE/LKV Convenience Pack Anaerobe Systems 2
Pras Yeast Casitone Fatty Acid Agar w/ Carbohydrates & Sheep Blood (Ycfac-B) Anaerobe Systems 2
BD BBL™ Brain Heart Infusion Agar with 5% Sheep Blood Slants Becton, Dickinson AND Company 2
BD BBL™ Columbia Agar with 5% Sheep Blood Becton, Dickinson AND Company 2

Showing 12 of 46. All products under Culture Media, Enriched

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