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IMMUNOSTICS, INC.

Last updated September 17, 2026

Information

Country: US
Address: 38 Industrial Way E Ste 1, Eatontown, NJ, 07724
Website: —
LinkedIn: —
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Email: —
Phone: —
PRRC Contact: —
EUDAMED SRN: —
FDA FEI Number: 2244821
DUNS Number: —

Catalogue (123)

Page 1 of 3

Device	Model / Reference	Registries	Class	Status
hema-screen SPECIFIC	HSSPCAS-125	FDA UDI	Class II	Active
To Life HCG Pregnancy Test Strip	2010	FDA UDI	Class II	Active
hema-screen 340 Test	HS-340	FDA UDI	Class II	Active
hemochroma PLUS Analyzer	100-101	FDA UDI	Class II	Active
hema-screen SPECIFIC	BUF17-200	FDA UDI	Class II	Active
Detector hCG Combi	IDC-100	FDA UDI	Class II	Active
Early Discovery	HSED-3	FDA UDI	Class II	Active
Detector Drug Cup	HCDOAV-154	FDA UDI	Class II	Active
Detector UA 10SG	IDU-10SG	FDA UDI	Class I	Active
hema-screen STAT	HSTAT-50	FDA UDI	Class II	Active
Detector Color IM	IMC-50	FDA UDI	Class II	Active
Detector Drug Cup	HCDOAV-3104	FDA UDI	Class II	Active
Detector H. pylori	IHP-30	FDA UDI	Class I	Active
Detector UA 10	IDU-10	FDA UDI	Class I	Active
hema-screen SPECIFIC	BUF17-100	FDA UDI	Class II	Active
Detector RPR	RPR-1002C	FDA UDI	Class II	Active
Detector hCG Personal	IDP-100	FDA UDI	Class II	Active
Detector hCG	IHDOTC	FDA UDI	Class II	Active
hema-screen	HS-1000	FDA UDI	Class II	Active
Detector Drug Cup	HCDOAV-4125	FDA UDI	U	Active
Detector Lex-CRP	CRP-50	FDA UDI	Class II	Active
Detector Lex-IM	IMLX-100	FDA UDI	Class II	Active
Detector hCG	IHD/P-25	FDA UDI	Class II	Active
hema-screen ER	HSER-100	FDA UDI	Class II	Active
hema-screen Mailing Envelopes	HSME-100	FDA UDI	Class II	Active
Detector Monocol	IMM-100	FDA UDI	Class II	Active
hema-screen SPECIFIC	DEV-125	FDA UDI	Class II	Active
To Life	2030	FDA UDI	Class II	Active
Detector RPR	RPR-5003C	FDA UDI	Class II	Active
AC&C DeTec hCG Pregnancy Test Device	3025	FDA UDI	Class II	Active
hema-screen ER	HSER-34	FDA UDI	Class II	Active
Detector Monocol Lex	MCLX-100	FDA UDI	Class II	Active
Detector hCG	IHD/P-25OR	FDA UDI	Class II	Active
Detector Monocol	IMM-50	FDA UDI	Class II	Active
Detector Lex SLE	SLE-100	FDA UDI	Class II	Active
hema-screen	HS-34	FDA UDI	Class II	Active
hemochroma PLUS Optical System Check	100-404	FDA UDI	Class II	Active
Detector Monocol Lex	MCLX-50	FDA UDI	Class II	Active
Am I Pregnant?	5050M2-3B	FDA UDI	Class II	Active
Detector Strep A	IST-501-OBC33	FDA UDI	Class I	Active
Detector H. pylori	IHP-10	FDA UDI	Class I	Active
hema-screen SPECIFIC	HSSP-25	FDA UDI	Class II	Active
hema-screen ER	HSTRER-100	FDA UDI	Class II	Active
hema-screen ER	HSPP-50ER	FDA UDI	Class II	Active
Detector hCG	IHD/P-50	FDA UDI	Class II	Active
hema-screen ER	HSER-50	FDA UDI	Class II	Active
Detector hCG Stick	IHS-50	FDA UDI	Class II	Active
hemochroma PLUS Control	100-303	FDA UDI	Class II	Active
Detector hCG Combi	IDC-50	FDA UDI	Class II	Active
Detector Rheumacol Lex	RHLX-100	FDA UDI	Class II	Active

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FDA Recalls (1)

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
Aug 25, 2023	Z-0702-2024	—	open, classified	Labeling for affected lots incorrectly indicates the expiration date is 10/31/2023. However, the correct expiration date is 10/31/2022. Use of the product after its expiration may cause false positive, false negative, or invalid results.