Is Iso-Tex Diagnostics, Inc. FDA approved?

Iso-Tex Diagnostics, Inc. holds 1 FDA-registered establishment in the United States. Registration puts a site on the FDA's register and open to inspection; it is not an approval of the company. Approvals attach to individual drug applications.

Where are Iso-Tex Diagnostics, Inc.'s drugs manufactured?

The FDA register lists Alvin, TX. Registered operations: analytical testing, finished drug manufacture.

What drugs does Iso-Tex Diagnostics, Inc. make?

3 products are listed under Iso-Tex Diagnostics, Inc. in the openFDA NDC Directory, most often as injection, solution. The full breakdown by dosage form and route is above. A listing count is not a sales figure.

Iso-Tex Diagnostics, Inc.

Data as of 24 Sept 2026 · How to read this entry

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Registered sites: 1
Active NDC listings: 3
Live patents: 0
Countries: 1
Base: United States

Authorisation

Registered operations

Analytical testing1Finished drug manufacture1

Sites

Registered establishments

Establishment	Address	Registered for	FEI / DUNS
Iso-Tex Diagnostics, Inc.	1511 County Road 129, Alvin, Texas (TX) 77511, United States (USA)	Analytical testing, Finished drug manufacture	1626310181202995

Catalogue

Drug listings by form and route

3 active NDC listings: 3 human prescription drug. By marketing category: BLA 2, NDA 1.

Dosage form	NDCs
injection, solution	3

Route	NDCs
intravenous	3

Labeller name on the listing	NDCs
iso-tex diagnostics, inc.	3

Catalogue

Marketed products

Brand	Generic name	Form / route	NDC
Glofil-125	Sodium Iothalamate I-125 injection	injection, solution, intravenous	50914-7729NDA
Megatope	Iodinated I-131 Albumin	injection, solution, intravenous	50914-7731BLA
Volumex	Iodinated I-131 Albumin	injection, solution, intravenous	50914-7720BLA

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Enquiry

Common questions

Is Iso-Tex Diagnostics, Inc. FDA approved?: Iso-Tex Diagnostics, Inc. holds 1 FDA-registered establishment in the United States. Registration puts a site on the FDA's register and open to inspection; it is not an approval of the company. Approvals attach to individual drug applications.
Where are Iso-Tex Diagnostics, Inc.'s drugs manufactured?: The FDA register lists Alvin, TX. Registered operations: analytical testing, finished drug manufacture.
What drugs does Iso-Tex Diagnostics, Inc. make?: 3 products are listed under Iso-Tex Diagnostics, Inc. in the openFDA NDC Directory, most often as injection, solution. The full breakdown by dosage form and route is above. A listing count is not a sales figure.

Compiled from FDA establishment registrations, the openFDA NDC Directory, the Orange Book and the FDA drug shortage database. Not claimed by the company. Sources and methodology.