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DRG International, Inc.

Last updated September 17, 2026

Information

Country: US
Address: 841 Mountain Ave, Springfield, NJ, 07081
Website: —
LinkedIn: —
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Email: —
Phone: —
PRRC Contact: —
EUDAMED SRN: —
FDA FEI Number: 2245285
DUNS Number: —

Catalogue (212)

Page 1 of 5

Device	Model / Reference	Registries	Class	Status
25 OH Vitamin D Total (90') ELISA	EIA-6087	FDA UDI	Class II	Active
Bordetella pertussis IgG ELISA	EIA-3450	FDA UDI	Class I	Active
Anti-dsDNA IgM ELISA	EIA-3564	FDA UDI	Class II	Unknown
Free Thyroxine (fT4) ELISA	EIA-4266	FDA UDI	Class II	Active
Taenia Solium IgG ELISA	EIA-3513	FDA UDI	Class I	Active
Myoglobin ELISA	EIA-3955	FDA UDI	Class II	Unknown
T3-Uptake ELISA	EIA-3267	FDA UDI	Class II	Active
LH-Serum ELISA	EIA-1289	FDA UDI	Class I	Active
Lysozyme (Food) ELISA	EIA-6027	FDA UDI	Class I	Unknown
Rheumatoid Factor IgM ELISA	EIA-3585	FDA UDI	Class II	Active
SSB (La) IgG ELISA	EIA-2783	FDA UDI	Class II	Active
Varicella Zoster Virus (VZV) IgG ELISA	EIA-2808	FDA UDI	Class II	Active
Free Testosterone ELISA	EIA-6101	FDA UDI	Class I	Active
Galactose (with Membrane Plate) ELISA	EIA-1486	FDA UDI	Class I	Unknown
T3 Total ELISA	EIA-4569	FDA UDI	Class II	Active
Anti-SS-A (Ro) ELISA	EIA-3573	FDA UDI	Class II	Active
Echinococcus IgG ELISA	EIA-3472	FDA UDI	Class I	Active
Epstein Barr Virus VCA IgG ELISA	EIA-2793	FDA UDI	Class I	Unknown
T-3	HYE-5697	FDA UDI	Class II	Active
Human Growth Hormone (HGH) ELISA	EIA-1787	FDA UDI	Class I	Active
Anti-Cardiolipin IgG/IgM ELISA	EIA-3587	FDA UDI	Class II	Active
Triiodothyronine (T3) ELISA	EIA-1780	FDA UDI	Class II	Active
Free Triiodothyronine (fT3) ELISA	EIA-2385	FDA UDI	Class II	Active
ACTH (Adrenocorticotropic Hormone) ELISA	EIA-3647	FDA UDI	Class II	Active
Galactose (without Membrane Plate) ELISA	EIA-1487	FDA UDI	Class I	Unknown
Free Estriol	HYE-5351	FDA UDI	Class I	Active
Ascaris IgG ELISA	EIA-5854	FDA UDI	Class I	Active
Progesterone	HYE-5368	FDA UDI	Class I	Active
Thyrotropin (TSH) ELISA	EIA-4111	FDA UDI	Class II	Active
Histamine ELISA	EIA-5827	FDA UDI	Class I	Active
Free Triiodothyronine (fT3) ELISA	EIA-5277	FDA UDI	Class II	Active
Ureaplasma urealyticum IgG ELISA	EIA-4623	FDA UDI	Class I	Unknown
Estrone ELISA	EIA-4174	FDA UDI	Class I	Active
ENA Screen ELISA	EIA-3571	FDA UDI	Class II	Active
Epstein Barr Virus VCA IgM ELISA	EIA-2794	FDA UDI	Class I	Unknown
Anti-Lactoferrin ELISA	EIA-3602	FDA UDI	Class II	Unknown
Dhea Elisa	EIA-3415	FDA UDI	Class I	Active
DNA (ds) IgG ELISA	EIA-2774	FDA UDI	Class II	Unknown
H. Pylori IgG ELISA	EIA-2815	FDA UDI	Class I	Unknown
Progesterone (serum)	CLA-4663	FDA UDI	Class I	Active
Galactose (with Membrane Plate) ELISA	EIA-1488	FDA UDI	Class I	Unknown
Bordetella pertussis Toxin (PT) IgG ELISA	EIA-6133	FDA UDI	Class I	Unknown
Anti-RNP/Sm ELISA	EIA-3578	FDA UDI	Class II	Active
Measles Virus IgG ELISA	EIA-3844	FDA UDI	Class I	Active
HGH (Human Growth Hormone) ELISA	EIA-3552	FDA UDI	Class I	Unknown
Gliadin IgA ELISA	EIA-3370	FDA UDI	Class II	Active
Pregnenolone ELISA	EIA-4912	FDA UDI	Class I	Unknown
Micro-Albumin ELISA	EIA-3881	FDA UDI	Class I	Unknown
Mycoplasma hominis IgG ELISA	EIA-4559	FDA UDI	Class II	Unknown
Mumps Virus IgG ELISA	EIA-3846	FDA UDI	Class I	Active

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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.