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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 3 of 5

Device	Model / Reference	Registries	Class	Status
Anti-Scl-70 ELISA	EIA-3580	FDA UDI	Class II	Active
Cornybacterium diphtheriae toxin IgG ELISA	EIA-3824	FDA UDI	Class I	Active
Progesterone ELISA	EIA-1561	FDA UDI	Class I	Active
Neonatal TSH ELISA	EIA-1483	FDA UDI	Class II	Unknown
Borrelia burgdorferi IgG (Lyme) ELISA	EIA-2810	FDA UDI	Class II	Active
Rheumatoid Factor Screen ELISA	EIA-3583	FDA UDI	Class II	Active
Salivary 17-OH Progesterone ELISA	SLV-3140	FDA UDI	Class I	Active
T-4 Total ELISA	EIA-4568	FDA UDI	Class II	Active
Influenza Virus B IgG ELISA	EIA-3796	FDA UDI	Class I	Active
Strongyloides IgG ELISA	EIA-4208	FDA UDI	Class I	Active
Tgf-B2 Elisa	EIA-2396	FDA UDI	Class I	Active
Sm RNP IgG ELISA	EIA-2785	FDA UDI	Class II	Active
ENA Screen (entractable nuclear antigen) ELISA	EIA-2779	FDA UDI	Class II	Active
TPO IgG ELISA	EIA-2791	FDA UDI	Class II	Active
Prolactin ELISA	EIA-1291	FDA UDI	Class I	Active
ANA Detect ELISA	EIA-4117	FDA UDI	Class II	Active
Drugs of Abuse Five (5) Panel Test	RAP-3773	FDA UDI	Class II	Unknown
Androstenedione	HYE-5339	FDA UDI	Class I	Active
Mumps IgM ELISA	EIA-3847	FDA UDI	Class I	Active
Total Thyroxine (T4) ELISA	EIA-1781	FDA UDI	Class II	Active
Thyroid Stimulating Hormone (TSH) ELISA	EIA-1782	FDA UDI	Class II	Active
Proinsulin ELISA	EIA-1560	FDA UDI	Class I	Unknown
Salivary Estradiol ELISA	SLV-4188	FDA UDI	Class I	Active
Anti-Sm ELISA	EIA-3577	FDA UDI	Class II	Active
RF IgM (Rheumatoid Factor) ELISA	EIA-2775	FDA UDI	Class II	Unknown
Borrelia burgdorferi IgM (Lyme) ELISA	EIA-2811	FDA UDI	Class II	Active
Beta-2 Microglobulin ELISA	EIA-1789	FDA UDI	Class II	Active
LH-Urine ELISA	EIA-1290	FDA UDI	Class I	Active
Lysozyme (stool) ELISA	EIA-6100	FDA UDI	Class I	Unknown
Rickettsia IgG ELISA	EIA-5297	FDA UDI	Class I	Active
Coxiella burnetii (Q-Fever) Phase 2 IgG ELISA	EIA-5189	FDA UDI	Class I	Active
Retinol binding Protein (RBP)/RBP4 ELISA	EIA-4391	FDA UDI	Class I	Active
Measles Virus IgG Avidity ELISA	EIA-5967	FDA UDI	Class I	Unknown
HCG midstream Test	RAP-2822	FDA UDI	Class II	Unknown
Entamoeba histolytica Ag (stool) ELISA	EIA-3473	FDA UDI	Class II	Unknown
ANA Screen IgG ELISA	EIA-2773	FDA UDI	Class II	Unknown
Cardiolipin IgA ELISA	EIA-2790	FDA UDI	Class II	Active
Follicle Stimulating Hormone (FSH) ELISA	EIA-1785	FDA UDI	Class I	Unknown
21-Hydroxylase Autoantibody ELISA	EIA-5955	FDA UDI	Class II	Active
C-Peptide ELISA	EIA-1293	FDA UDI	Class I	Active
Giardia lamblia Antigen (stool) ELISA	EIA-3477	FDA UDI	Class II	Unknown
Galactose (without Membrane Plate) ELISA	EIA-1489	FDA UDI	Class I	Unknown
Fsh Elisa	EIA-1288	FDA UDI	Class I	Active
ANCA Screen IgG ELISA	EIA-2777	FDA UDI	Class II	Active
Free Thyroxine (fT4) ELISA	EIA-4109	FDA UDI	Class II	Active
SSA (Ro) ELISA	EIA-2782	FDA UDI	Class II	Active
Coxiella burnetii (Q-Fever) Phase 1 IgG ELISA	EIA-5188	FDA UDI	Class I	Active
Salivary Estradiol HS ELISA	SLV-6145	FDA UDI	Class I	Active
EPO (Erythropoietin) ELISA	EIA-3646	FDA UDI	Class II	Active
Anti TPO Ab ELISA	EIA-3561	FDA UDI	Class II	Unknown

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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.