Pantex, Div. Bio-Analysis, Inc.

United StatesFDA applicant, unverified

Devices: 16

What Pantex, Div. Bio-Analysis, Inc. makes

Pantex, Division of Bio-Analysis, Inc. manufactures diagnostic assay kits for hormone and biomarker testing, including enzyme immunoassays (ELISA), radioimmunoassays (RIA), and immunomagnetic assays (IRMA). Their products measure salivary and serum cortisol, thyroid hormones (T3, T4, TSH), luteinizing hormone (LH), follicle-stimulating hormone (FSH), progesterone, testosterone, DHEA-S, 17-hydroxyprogesterone, and estradiol. These kits are designed for laboratory use in clinical and neonatal screening applications, such as newborn blood spot testing.

The company’s diagnostic assays are classified under FDA’s Class I and Class II regulatory categories, with submissions recorded in the FDA’s 510(k) database. Products are intended for in vitro use and comply with U.S. regulatory requirements. The manufacturer is based in the United States.

AI-generated from registry data, 2 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue16

Newest first, rows 1-16 of 16

Search and filter all 16 devices

Pantex Am/Pm Salivary Cortisol Enzyme Immunoassay Ref K102841

Active Regimes: 510(k) Registry: 510(k) Class:II
Pancoat T4 Coated Tube Radioimmunoassay Kit Ref K854324

Active Regimes: 510(k) Registry: 510(k) Class:II
Fsh Irma Immunomag Ref K912804

Active Regimes: 510(k) Registry: 510(k) Class:I
Immunocoat Progesterone Radioimmunoassay Kit Ref K894049

Active Regimes: 510(k) Registry: 510(k) Class:I
Pantex Direct Dhea-S Coated Tube Radioimmunoassay Ref K853867

Active Regimes: 510(k) Registry: 510(k) Class:I
Pancoat T3 Uptake Coated Tube Radioimmunoassay Kit Ref K862447

Active Regimes: 510(k) Registry: 510(k) Class:II
Pancoat Cortisol Coated Tube Radioimmunoassay Kit Ref K862336

Active Regimes: 510(k) Registry: 510(k) Class:II
Pantex Irma Lh 1251 Kit Ref K910717

Active Regimes: 510(k) Registry: 510(k) Class:I
Neoscreen Elisa Tsh Ref K942658

Active Regimes: 510(k) Registry: 510(k) Class:II
Neonatal Blood Spot Test 17-Hydroxprog Radio Kit Ref K911839

Active Regimes: 510(k) Registry: 510(k) Class:I
17B Estradiol Ref K810204

Active Regimes: 510(k) Registry: 510(k) Class:I
Pantex Direct Testosterone Coated Tube Radioimmuno Ref K853865

Active Regimes: 510(k) Registry: 510(k) Class:I
Prolactin Irma Immunomag Ref K914107

Active Regimes: 510(k) Registry: 510(k) Class:I
Lh Irma Immunomag Ref K911050

Active Regimes: 510(k) Registry: 510(k) Class:I
Pantex Fte Free Testosterone Radioimmunoassay Kit Ref K862483

Active Regimes: 510(k) Registry: 510(k) Class:I
Pantex Direct Estradiol Coated Tube Radioimmunoass Ref K853866

Active Regimes: 510(k) Registry: 510(k) Class:I

Rows 1-16 of 16

Frequently asked questions

How many devices does Pantex, Div. Bio-Analysis, Inc. have in the registry?

The registry currently lists 16 devices for Pantex, Div. Bio-Analysis, Inc.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Pantex, Div. Bio-Analysis, Inc.'s devices?

Among its 16 most recently registered devices, Pantex, Div. Bio-Analysis, Inc. has devices listed in FDA 510(k) (16 devices).

What risk classes do Pantex, Div. Bio-Analysis, Inc.'s devices fall under?

Among its 16 most recently registered devices, the classes recorded for Pantex, Div. Bio-Analysis, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.

What are the newest devices from Pantex, Div. Bio-Analysis, Inc. in the registry?

The most recently registered devices listed for Pantex, Div. Bio-Analysis, Inc. include PANTEX AM/PM SALIVARY CORTISOL ENZYME IMMUNOASSAY, PANCOAT T4 COATED TUBE RADIOIMMUNOASSAY KIT, FSH IRMA IMMUNOMAG and IMMUNOCOAT PROGESTERONE RADIOIMMUNOASSAY KIT.

Generated automatically from registry data and not verified by a human reviewer.

What Pantex, Div. Bio-Analysis, Inc. makes

Catalogue16

Pantex Am/Pm Salivary Cortisol Enzyme Immunoassay Ref K102841

Pancoat T4 Coated Tube Radioimmunoassay Kit Ref K854324

Fsh Irma Immunomag Ref K912804

Immunocoat Progesterone Radioimmunoassay Kit Ref K894049

Pantex Direct Dhea-S Coated Tube Radioimmunoassay Ref K853867

Pancoat T3 Uptake Coated Tube Radioimmunoassay Kit Ref K862447

Pancoat Cortisol Coated Tube Radioimmunoassay Kit Ref K862336

Pantex Irma Lh 1251 Kit Ref K910717

Neoscreen Elisa Tsh Ref K942658

Neonatal Blood Spot Test 17-Hydroxprog Radio Kit Ref K911839

17B Estradiol Ref K810204

Pantex Direct Testosterone Coated Tube Radioimmuno Ref K853865

Prolactin Irma Immunomag Ref K914107

Lh Irma Immunomag Ref K911050

Pantex Fte Free Testosterone Radioimmunoassay Kit Ref K862483

Pantex Direct Estradiol Coated Tube Radioimmunoass Ref K853866

Frequently asked questions