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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 2 of 5

Device	Model / Reference	Registries	Class	Status
Corticosterone ELISA	EIA-4164	FDA UDI	Class I	Active
Sample Preparation System (Stool)	EIA-5674	FDA UDI	Class I	Active
B. burgdorferi IgG/IgM ELISA	EIA-2809	FDA UDI	Class II	Active
Testosterone ELISA	EIA-1559	FDA UDI	Class I	Active
Prolactin ELISA	EIA-1786	FDA UDI	Class I	Unknown
Fsh	HYE-5355	FDA UDI	Class I	Active
T3-Uptake ELISA	EIA-5266	FDA UDI	Class II	Active
Free Estriol ELISA	EIA-1612	FDA UDI	Class I	Active
Igf-1 600 Elisa	EIA-4140	FDA UDI	Class I	Active
Dhea-S	HYE-5347	FDA UDI	Class I	Active
Human Chorionic Gonadotropin (hCG) ELISA	EIA-1783	FDA UDI	Class II	Unknown
Anti-Cardiolipin Screen ELISA	EIA-3589	FDA UDI	Class II	Unknown
Anti-SS-B ELISA	EIA-3576	FDA UDI	Class II	Unknown
ENA-6-Profile ELISA	EIA-2780	FDA UDI	Class II	Unknown
Calcitonin ELISA	EIA-3648	FDA UDI	Class II	Active
Immunoglobulin E (IgE) ELISA	EIA-1788	FDA UDI	Class II	Active
Serotonin ELISA	EIA-1300	FDA UDI	Class I	Unknown
Influenza Virus A IgG ELISA	EIA-3793	FDA UDI	Class I	Active
HCG dipstick Test	RAP-2818	FDA UDI	Class II	Unknown
Anti-Insulin ELISA	EIA-3608	FDA UDI	Class I	Active
Sperm Antibody ELISA	EIA-1826	FDA UDI	Class I	Active
Trichinella spiralis IgG ELISA	EIA-3866	FDA UDI	Class I	Active
Dhea-S Elisa	CLA-4652	FDA UDI	Class I	Active
T3 free	HYE-5356	FDA UDI	Class II	Active
Toxocara IgG ELISA	EIA-3518	FDA UDI	Class II	Active
ANA-8-Profile ELISA	EIA-3563	FDA UDI	Class II	Active
Trichinella spiralis IgG ELISA	EIA-3521	FDA UDI	Class I	Active
Cardiolipin IgG ELISA	EIA-2788	FDA UDI	Class II	Active
Insulin	HYE-5361	FDA UDI	Class I	Active
Sperm Antibody ELISA	EIA-4249	FDA UDI	Class I	Active
RF IgG (Rheumatoid Factor) ELISA	EIA-3584	FDA UDI	Class II	Active
Aspergillus fumigatus IgG ELISA	EIA-6129	FDA UDI	Class I	Active
Vitamin C (Ascorbic Acid)	ENZ-4888	FDA UDI	Class I	Active
Free T3 ELISA	EIA-3801	FDA UDI	Class II	Active
Progesterone, 17-a-OH	CLA-4665	FDA UDI	Class I	Unknown
Myeloperoxidase IgG ELISA	EIA-2776	FDA UDI	Class II	Active
Anti-Cardiolipin IgA ELISA	EIA-3588	FDA UDI	Class II	Active
Total Thyroxine (tT4) ELISA	EIA-5279	FDA UDI	Class II	Active
Rheumatoid Factor IgA ELISA	EIA-3586	FDA UDI	Class II	Active
Schistosoma IgG ELISA	EIA-3512	FDA UDI	Class I	Active
DRG:HYBRiD.XL®	HYB-5252	FDA UDI	Class I	Active
Estrone Serum ELISA	CLA-4654	FDA UDI	Class I	Active
Dhea-S Elisa	EIA-1562	FDA UDI	Class I	Active
Cardiolipin IgM ELISA	EIA-2789	FDA UDI	Class II	Active
PTH (Parathyroid) Intact ELISA	EIA-3645	FDA UDI	Class II	Active
TSH (ultrasensitive) ELISA	EIA-1790	FDA UDI	Class II	Active
Progesterone, 17 a-Hydroxy- (Neonate) (MW) ELISA	EIA-1429	FDA UDI	Class I	Active
EBV-EA IgG ELISA	EIA-2796	FDA UDI	Class I	Unknown
RSV IgG ELISA	EIA-3057	FDA UDI	Class I	Active
Insulin ELISA	EIA-2935	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.