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 15, 2026, FDA's public records list DRG International with 7 device recalls and 6 510(k) clearances. The most recent is a device recall dated Jul 2, 2026: Sperm Ab ELISA; Model/Catalog Number: EIA-1826; Product Description: Sperm Ab ELISA (9….
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.
| Jul 2, 2026 | Sperm Ab ELISA; Model/Catalog Number: EIA-1826; Product Description: Sperm Ab ELISA (96 well plate test);Class II · Potential for false negative patient results. | Device recalls |
| Jun 4, 2025 | Brand Name: T4 Total ELISA Product Name: T4 Total ELISA Model/Catalog Number: EIA-4568 Product Description: T4 Total ELISAClass III · An incoming complaint reported that the expiration date on the kit box label and Certificate of Analysis (CoA) exceeded | Device recalls |
| Oct 7, 2024 | DRG:HYBRiD-XL Insulin. Model/Catalog Number: HYE-5361Class II · The user of the assay may either face a failure message during re-calibration of the Hybrid.XL instrument using the re-c | Device recalls |
| Sep 13, 2024 | 17-OH Progesterone ELISA 96 well kit- An enzyme immunoassay for the quantitative in vitro diagnostic measurement of 17-OH Progesterone (17-OClass III · The High and Low Control acceptance ranges in the Certificate of Analysis (CofA) did not match the acceptance range info | Device recalls |
| Jul 5, 2024 | Product Name: Salivary Testosterone ELISA Model/Catalog Number: SLV-3013 Product Description: An enzyme immunoassay for the quantitative iClass III · Invalid Controls. The Low Control is out of range; too high which causes invalid runs that would result in repeating th | Device recalls |
| Dec 21, 2021 | C-Peptide ELISA : IVD measurement of C-Peptide in serum, plasma (EDTA-, heparin- or citrate plasma) and urine. Catalog # EIA-1293Class II · ODs of the standards too low(< 0.6 ODmax) may cause invalid runs, delayed patient results are possible | Device recalls |
| Oct 18, 2021 | Total Thyroxine (T4) ELISA; REF EIA-1781Class II · Firm has identified two lots of product that do not meet product shelf life, resulting in failed Controls. The clinical | Device recalls |
| Jan 29, 2008 | ENZYME IMMUNOASSAY FOR THE DETECTION OF SALIVARY 17-A-HYDROXYPROGESTERONEK062534 · JLX | 510(k) clearances |
| Jan 27, 2006 | DRG SLV TESTOSTERONE ELISA TESTK052649 · CDZ | 510(k) clearances |
| Dec 7, 2005 | ENZYME IMMUNOASSAY FOR THE DETECTION OF SALIVARY CORTISOLK051733 · NHG | 510(k) clearances |
| Apr 17, 2000 | DRG AURICA ELISA TESTOSTERONE KITK000043 · CDZ | 510(k) clearances |
| Apr 21, 1989 | KAMED STETHOSCOPEK890126 · LDE | 510(k) clearances |
| Sep 6, 1985 | D300 PORT ULTRASOUND LIN SCAN W/3.5 & 5.0 MHZ PROBK844184 · IYO | 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
