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DRG International, Inc.

Last updated September 17, 2026

Information

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

Catalogue (212)

Page 4 of 5

Device	Model / Reference	Registries	Class	Status
Thyrotropin (TSH) ELISA	EIA-5283	FDA UDI	Class II	Active
Salivary Testosterone ELISA	SLV-3013	FDA UDI	Class I	Active
Lh Elisa	EIA-4103	FDA UDI	Class I	Active
Lh	HYE-5362	FDA UDI	Class I	Active
E. Histolytica IgG ELISA	EIA-3474	FDA UDI	Class II	Active
Leptopspira IgG ELISA	EIA-4245	FDA UDI	Class II	Active
Gliadin IgG ELISA	EIA-3371	FDA UDI	Class II	Unknown
TSH Receptor Autoantibody ELISA	EIA-3369	FDA UDI	Class II	Active
pANCA (MPO) ELISA	EIA-3597	FDA UDI	Class II	Active
c-ANCA (PR3) ELISA	EIA-3596	FDA UDI	Class II	Unknown
Free Testosterone ELISA	EIA-4638	FDA UDI	Class I	Active
Cotinine ELISA	EIA-5917	FDA UDI	Class I	Active
Mycoplasma pneumoniae IgG ELISA	EIA-3499	FDA UDI	Class I	Active
Androstenedione ELISA	EIA-3265	FDA UDI	Class I	Active
Anti TG Ab ELISA	EIA-3708	FDA UDI	Class II	Active
Entamoeba histolytica IgG ELISA	EIA-3830	FDA UDI	Class II	Active
Pregnenolone Direct ELISA	EIA-4170	FDA UDI	Class I	Active
Jo-1 IgG ELISA	EIA-2787	FDA UDI	Class II	Active
Brucella IgG ELISA	EIA-3455	FDA UDI	Class II	Active
Tgf-B1 Elisa	EIA-1864	FDA UDI	Class I	Unknown
Proteinase-3 IgG ELISA	EIA-2778	FDA UDI	Class II	Active
Anti-SS-B ELISA	EIA-3576	FDA UDI	Class II	Active
Estradiol Sensitive ELISA	EIA-4399	FDA UDI	Class I	Active
ANA-8-Screen ELISA	EIA-3562	FDA UDI	Class II	Active
ENA-6-Profile ELISA	EIA-3901	FDA UDI	Class II	Active
Ferritin ELISA	EIA-1872	FDA UDI	Class II	Unknown
Sci-70 IgG ELISA	EIA-2786	FDA UDI	Class II	Active
Prolactin	HYE-5369	FDA UDI	Class I	Active
Free Triiodothyronine (fT3) ELISA	EIA-4107	FDA UDI	Class II	Active
Estradiol (serum)	CLA-4664	FDA UDI	Class I	Active
Fsh Elisa	EIA-4098	FDA UDI	Class I	Active
Legionella pneumophila IgG ELISA	EIA-5645	FDA UDI	Class II	Active
Estradiol	HYE-5349	FDA UDI	Class I	Active
Anti-dsDNA IgG ELISA	EIA-3438	FDA UDI	Class II	Active
Adenovirus Antigen (stool) ELISA	EIA-3444	FDA UDI	Class I	Unknown
Salivary Progesterone HS ELISA	SLV-5911	FDA UDI	Class I	Active
Candida albicans IgG ELISA	EIA-3458	FDA UDI	Class II	Active
Cryptosporidium Antigen (stool) ELISA	EIA-3467	FDA UDI	Class II	Unknown
Dengue Virus NS1 Ag ELISA	EIA-6090	FDA UDI	Class II	Active
Anti-Jo-1 ELISA	EIA-3581	FDA UDI	Class II	Active
Anti-Thyroid Peroxidase (Anti-TPO) ELISA	EIA-4114	FDA UDI	Class II	Active
Estrone ELISA	EIA-4079	FDA UDI	Class I	Active
Leptospira IgG ELISA	EIA-5751	FDA UDI	Class II	Active
Anti-dsDNA IgA ELISA	EIA-3565	FDA UDI	Class II	Unknown
Progesterone (17-a-OH Progesterone)	HYE-5333	FDA UDI	Class I	Active
C-Reactive Protein HS ELISA	EIA-3954	FDA UDI	Class II	Active
Total Triiodothyronine (tT3) ELISA	EIA-5275	FDA UDI	Class II	Active
CMV IgG ELISA	EIA-2797	FDA UDI	Class II	Active
Sm IgG ELISA	EIA-2784	FDA UDI	Class II	Active
Salivary Progesterone ELISA	SLV-2931	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.