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ALERE NORTH AMERICA, LLC

Last updated May 27, 2026

What ALERE NORTH AMERICA, LLC makes

The company manufactures in vitro diagnostic (IVD) test kits for detecting specific antibodies and antigens in clinical and point-of-care settings. These include agglutination-based tests for syphilis (Treponema pallidum reagin), streptococcal infections (Group A Streptococcus), and Epstein-Barr virus (EBV), as well as rapid colorimetric and enzyme immunoassay (EIA) tests for faecal occult blood and rubella IgG antibodies. Multiplex assays for rheumatoid arthritis-associated antibodies and rapid immunochromatographic tests (ICT) are also part of the portfolio.

The portfolio comprises devices classified as Class I and Class II under FDA regulations, with all products listed in the FDA’s Unique Device Identification (UDI) system. The manufacturer operates within the United States, adhering to applicable regulatory requirements for in vitro diagnostics.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Information

Country: US
Address: —
Website: alere.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: 1-877-441-7440
PRRC Contact: —
EUDAMED SRN: —
FDA FEI Number: —
DUNS Number: 826027364

Catalogue (26)

Device	Model / Reference	Registries	Class	Status
Impact Rpr™ Dry Control Cards 10 Ea	61C2	FDA UDI	Class II	Active
Impact Rpr™ 30 Well Test Cards 100 Ea	61C7	FDA UDI	Class II	Active
Impact Rpr™ Dispensing Bottles 10 Ea	61C9	FDA UDI	Class II	Active
Impact Rpr™ Test Kit (5000 Tests)	60C4	FDA UDI	Class II	Active
Impact Rpr™ 10 Well Test Cards 300 Ea	61C5	FDA UDI	Class II	Active
Impact Rpr™ Liquid Control 3 X 1 Ml	61C3	FDA UDI	Class II	Active
Dencoccult™ Iii	L103E	FDA UDI	Class II	Active
Impact Rpr™ Pipets/Stirrers 250 Ea	62C4	FDA UDI	Class II	Active
Impact Rpr™ Antigen Suspension 3 X 3ml	61C0	FDA UDI	Class II	Active
Impact Rpr™ 30 Well Cards Kit (5000 Tests)	60C6	FDA UDI	Class II	Active
Wampole ColorCard® Streptozyme®	46050	FDA UDI	Class I	Active
Impact Rpr™ Antigen Suspension 10 X 3ml	61C1	FDA UDI	Class II	Active
Rheumatex®	34S2	FDA UDI	Class II	Active
Alere Rubella-plus®	84R2	FDA UDI	Class II	Active
Wampole ColorCard® Mono	27135	FDA UDI	Class II	Active
Acceava® Mono Cassette	92407	FDA UDI	Class II	Active
Impact Rpr™ 15 Well Test Cards 300 Ea	61C6	FDA UDI	Class II	Active
Wampole Colorcard® RF	36045	FDA UDI	Class II	Active
Impact Rpr™ 10 Well Test Cards 50 Ea	62C5	FDA UDI	Class II	Active
Impact Rpr™ Test Kit (500 Tests)	60C3	FDA UDI	Class II	Active
Immunex Crp®	71S2	FDA UDI	Class II	Active
Wampole ColorCard® ASO	47050	FDA UDI	Class I	Active
Impact Rpr™ Test Kit (50 Tests)	60C1	FDA UDI	Class II	Active
Impact Rpr™ Test Kit (150 Tests)	60C2	FDA UDI	Class II	Active
Impact Rpr™ Needle/Sheath 10 Ea	61C8	FDA UDI	Class II	Active
Impact Rpr™ Pipets/Stirrers 500 Ea	61C4	FDA UDI	Class II	Active

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