Company
DRG International, Inc.
FDA 510(k) clearances and medical device recalls filed under this name. Name variants (Inc, Corp, punctuation) are merged.
0510(k) clearances (0 in 12 months)
9recalls (1 in 12 months)
2recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| JSO | Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar | 2 |
| CDX | Radioimmunoassay, Total Thyroxine | 1 |
| CDZ | Radioimmunoassay, Testosterones And Dihydrotestosterone | 1 |
| CFP | Radioimmunoassay, Immunoreactive Insulin | 1 |
| DFQ | Sperm, Antigen, Antiserum, Control | 1 |
| JKD | Radioimmunoassay, C-Peptides Of Proinsulin | 1 |
| JLX | Radioimmunoassay, 17-Hydroxyprogesterone | 1 |
| KLI | Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| No clearances in this window. | |||
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 2, 2026 | DRG International, Inc. Sperm Ab ELISA;
Model/Catalog Number: EIA-1826;
Product Description: Sperm Ab ELISA (96 well plate test); Open, Classified |
DFQ | None listed |
| Aug 4, 2025 | DRG International, Inc. Brand Name: T4 Total ELISA
Product Name: T4 Total ELISA
Model/Catalog Number: EIA-4568
Product Description: T4 Total ELISA Open, Classified |
CDX | None listed |
| Jan 15, 2025 | DRG International, Inc. DRG:HYBRiD-XL Insulin. Model/Catalog Number: HYE-5361 Open, Classified |
CFP | None listed |
| Oct 29, 2024 | DRG International, Inc. 17-OH Progesterone ELISA 96 well kit- An enzyme immunoassay for the quantitative in vitro diagnostic measurement of 17-OH Progesterone (17-OHP) in serum or plasma
Model/Catalog Number: EIA-1292 Open, Classified |
JLX | None listed |
| Aug 15, 2024 | DRG International, Inc. Product Name: Salivary Testosterone ELISA
Model/Catalog Number: SLV-3013
Product Description: An enzyme immunoassay for the quantitative in vitro diagnostic measurement of free active testosterone in Open, Classified |
CDZ | K052649 |
| Dec 21, 2021 | DRG International, Inc. C-Peptide ELISA : IVD measurement of C-Peptide in serum, plasma (EDTA-, heparin- or citrate plasma) and urine.
Catalog # EIA-1293 Terminated |
JKD | None listed |
| Oct 18, 2021 | DRG International, Inc. Total Thyroxine (T4) ELISA; REF EIA-1781 Open, Classified |
KLI | K991432 |
| Mar 11, 2010 | DRG International Inc CHROMagar 0157;
5000 ml (29.2 g/L)
EE222; IVD
For In Vitro Diagnostic Use, CHROMagar is a trademark of Dr. A. Rambach; CHROMagar, Paris France.
Medium for the detection of Van A Van B VRE. The majori Terminated |
JSO | None listed |
| Mar 11, 2010 | DRG International Inc CHROMagar VRE Base;
5000 ml (67.3 g/L) IVD;
For InVitro Diagnostic Use; CHROMagar is a trademark of Dr. A Rambach;
CHROMagar, Paris, France
Medium for the detection of Van A Van B VRE. The majority Terminated |
JSO | None listed |