Is this your brand? Sign in to claim ownership.
Sign in to claim this brandDRG International, Inc.
US
Last updated September 17, 2026
Information
- Country
- US
- Address
- 841 Mountain Ave, Springfield, NJ, 07081
- Website
- —
- —
- —
- —
- Phone
- —
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- 2245285
- DUNS Number
- —
Catalogue (212)
Page 5 of 5| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Cotinine direct (serum/urine) ELISA (480 well) | EIA-5497 | FDA UDI | Class I | Unknown |
| Crosslaps Serum ELISA | EIA-2124 | FDA UDI | Class I | Active |
| Schistosoma mansoni IgG ELISA | EIA-3872 | FDA UDI | Class I | Active |
| Anti-dsDNA Screen ELISA | EIA-3566 | FDA UDI | Class II | Active |
| 17 OH Progesterone ELISA | EIA-1292 | FDA UDI | Class I | Active |
| Estradiol ELISA | EIA-2693 | FDA UDI | Class I | Active |
| Anti-Thyroglobulin (Anti-Tg) ELISA | EIA-4110 | FDA UDI | Class II | Active |
| Cotinine direct (serum/urine) ELISA (96 well) | EIA-5496 | FDA UDI | Class I | Unknown |
| a1-Microglobulin ELISA | EIA-5100 | FDA UDI | Class I | Unknown |
| Giardia/Cryptosporidium Ag (stool) ELISA | EIA-6059 | FDA UDI | Class II | Unknown |
| Dhea | HYE-5346 | FDA UDI | Class I | Active |
| Adenovirus IgG ELISA | EIA-3446 | FDA UDI | Class I | Active |
Related Companies
Authorised Representatives
No authorised representatives on record.
Importers
Not available yet.
Notified Bodies
Not available yet.
Authorities
Not available yet.
FDA Recalls (8)
Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.
| Date | Recall No. | Class | Status | Reason |
|---|---|---|---|---|
| Jun 4, 2025 | Z-2265-2025 | — | open, classified | An incoming complaint reported that the expiration date on the kit box label and Certificate of Analysis (CoA) exceeded the shelf life of the standards and control solutions in the kit by 2 months (i.e., 2026-03-31 instead of 2026-01-31). The expiration dates on the bottle labels were correct (i.e., 2026-01-31). |
| Oct 7, 2024 | Z-0921-2025 | — | open, classified | The user of the assay may either face a failure message during re-calibration of the Hybrid.XL instrument using the re-calibration R1 and R2 of the device or find controls out of specification (failed Control High) which causes a delay in results. |
| Sep 13, 2024 | Z-0258-2025 | — | open, classified | The High and Low Control acceptance ranges in the Certificate of Analysis (CofA) did not match the acceptance range information on the High and Low Control Component labels. Due to the defect, the device failed to provide results, which may result in a delay in obtaining test results and a remote chance of an adverse health risk. |
| Jul 5, 2024 | Z-2622-2024 | — | open, classified | Invalid Controls. The Low Control is out of range; too high which causes invalid runs that would result in repeating the runs and delays for reporting results to patients. |
| Dec 21, 2021 | Z-0896-2022 | — | terminated | ODs of the standards too low(< 0.6 ODmax) may cause invalid runs, delayed patient results are possible |
| Oct 18, 2021 | Z-0310-2022 | — | open, classified | Firm has identified two lots of product that do not meet product shelf life, resulting in failed Controls. The clinical impact may be a delay in diagnosis and a consumption of patient samples. |
| Nov 9, 2009 | Z-1068-2010 | — | terminated | CHROMagar Products are labeled incorrectly. Label currently states that the product is for IVD use, when it should state that the product is intended For Research Use, Not for use in diagnostic procedures. |
| Nov 9, 2009 | Z-1067-2010 | — | terminated | CHROMagar Products are labeled incorrectly. Label currently states that the product is for IVD use, when it should state that the product is intended For Research Use, Not for use in diagnostic procedures. |