Pantex

Salivary Progesterone Enzyme Immunoassay (1)

Registry build 21.09.26
4manufacturers in China registered for this device type
2catalogue numbers in this listing

Who Else Makes It

Concentrated in Hebei (1), Guangdong (1), Jiangsu (1).

Chinese manufacturers registered for FDA product code JLS
Manufacturer City Province Registered as Device types
Shijiazhuang Hipro Biotechnology Co., Ltd. Shijiazhuang Hebei Manufacturer 22
Shenzhen Yhlo Biotech Co., Ltd. Shenzhen Guangdong Manufacturer 19
Getein Biotech, Inc. Nanjing Jiangsu Manufacturer 19
Beijing Hotgen Biotech Co., Ltd. Beijing Beijing Manufacturer 13

Record

Regulatory record for Pantex
Listed by Pantex, United States
FDA product code JLS
Device type Radioimmunoassay, Progesterone
Device class Class 1
Regulation 21 CFR 862.1620
Record published 2023-02-17
Record revised 2023-03-31 (version 3)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Supplied as a kit Yes
Label carries lot or batch number, expiry date
Storage Storage environment temperature 2 to 8 °C
Distribution end date 2023-03-31

Catalogue Numbers

Catalogue numbers for Pantex
Catalogue number Size Status
N/A In distribution
N/A Withdrawn

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
MP Biomedicals LLC Mp Biomedicals, LLC 4
Elecsys Progesterone III Roche Diagnostics Gmbh 3
Alinity Abbott Ireland 3
Architect Abbott Ireland 3
Salimetrics Salimetrics LLC. 3
Atellica IM Prge Siemens Healthcare Diagnostics Inc 3
Salivary Progesterone Elisa DRG Instruments Gesellschaft mit beschränkter Haftung 2
Vitros Ortho-Clinical Diagnostics, Inc. 2
Immulite®/Immulite® 1000 Systems PRG Progesterone Siemens Healthcare Diagnostics Products GmbH 2
Salivary Progesterone HS Elisa DRG Instruments Gesellschaft mit beschränkter Haftung 2
Progesterone Luminescence Immunoassay IBL International Gmbh 2
Progesterone Elisa DRG Instruments Gesellschaft mit beschränkter Haftung 2

Showing 12 of 54. All products under Radioimmunoassay, Progesterone

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