Diagnostics makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in United StatesLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 3 spellings of its name, each linked to the record.
As of Nov 13, 2026, FDA's public records list Iso-Tex Diagnostics with 4 drug applications, 3 510(k) clearances and 2 drug recalls. The most recent is a drug recall dated Apr 15, 2019: Volumex (Iodinated I 131 Albumin) Injection USP, 25 uCi per 1 mL syringe, Rx Only, Manuf….
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Date | Record | Source |
|---|---|---|
| Apr 15, 2019 | Volumex (Iodinated I 131 Albumin) Injection USP, 25 uCi per 1 mL syringe, Rx Only, Manufactured for Daxor Corp., NY, NY; By: Iso-Tex DiagnosClass II · Lack of Assurance of Sterility: environmental monitoring report exceeds limits, therefore sterility cannot be assured. | Drug recalls |
| Mar 11, 2019 | Volumex (Iodinated I 131 Albumin) Injection USP, 25 uCi per 1 mL syringe, Rx Only, Manufactured for Daxor Corp., NY, NY; By: Iso-Tex DiagnosClass II · Lack of Assurance of Sterility: preliminary environmental monitoring report exceeds limits, therefore sterility cannot b | Drug recalls |
| Jul 10, 1985 | APO B RIA KITK851389 · MSJ | 510(k) clearances |
| Jan 10, 1984 | APO A-I RIA KIT-HUMAN PLASMA APOLIP-K840105 · | 510(k) clearances |
| Mar 21, 1979 | RIA SYSTEM, PARATHYROID HORMONEK782081 · CEW | 510(k) clearances |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
