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Minaris Medical America, Inc.

Last updated May 27, 2026

What Minaris Medical America, Inc. makes

The company produces in vitro diagnostic (IVD) devices for measuring allergen-specific and total immunoglobulin E (IgE) antibodies, including chemiluminescent immunoassay kits, controls, and semi-automated analysers. Examples include allergen-specific IgE assays for food and inhalant panels, negative and positive control reagents, and automated processing systems for laboratory use.

These devices are classified as Class II under FDA regulations and are listed in the FDA’s Unique Device Identifier (UDI) database. The company operates within the United States, adhering to applicable U.S. regulatory standards for IVD products.

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

Frequently asked questions

What does Minaris Medical America, Inc. manufacture?

Minaris Medical America, Inc. produces in vitro diagnostic (IVD) devices for measuring allergen-specific and total immunoglobulin E (IgE) antibodies. Their products include chemiluminescent immunoassay kits, control reagents, and semi-automated analysers for laboratory use.

Where is Minaris Medical America, Inc. based?

Minaris Medical America, Inc. is based in the United States. The company operates within the U.S. and adheres to applicable U.S. regulatory standards for their in vitro diagnostic products.

Which regulatory registries list Minaris Medical America's devices?

Minaris Medical America's devices are listed in the FDA's Unique Device Identifier (UDI) database. This registry provides information about medical devices, including their identification and classification status.

How are Minaris Medical America's devices classified?

Minaris Medical America's devices are classified as Class II under FDA regulations. Class II devices are those that require special controls to ensure their safety and effectiveness, such as performance standards and labeling requirements.

AI-generated from registry data and not verified by a human reviewer.

Information

Country: US
Address: —
Website: hcdiagnostics.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: +1(650)961-5501
PRRC Contact: —
EUDAMED SRN: —
FDA FEI Number: —
DUNS Number: 102113867

Catalogue (33)

Device	Model / Reference	Registries	Class	Status
CLA® Negative Control Serum	94173	FDA UDI	Class II	Active
CLA® Allergen-Specific IgE Assay - Pediatric Comprehensive Panel	84506	FDA UDI	Class II	Unknown
UP20 Negative Control Reagent	80108	FDA UDI	Class II	Unknown
OPTIGEN® Allergen-Specific IgE Assay - Food 29 (20T)	85067	FDA UDI	Class II	Active
CLA® Allergen-Specific IgE Assay - Eastern	84508	FDA UDI	Class II	Unknown
CLA® Allergen-Specific IgE Assay - Eastern	84502	FDA UDI	Class II	Active
OPTIGEN® Allergen-Specific IgE Assay - US Food 30 (40ND)	85167	FDA UDI	Class II	Active
CLA® Allergen-Specific IgE Assay - Southeastern Inhalant Panel	84507	FDA UDI	Class II	Active
OPTIGEN® US Panel Control Reagent	80109	FDA UDI	Class II	Active
OPTIGEN® Negative Control Reagent	82062	FDA UDI	Class II	Active
OPTIGEN® Allergen-Specific IgE Assay - Universal 20 Panel	85003	FDA UDI	Class II	Active
CLA® Allergen-Specific IgE Assay - Northeastern Inhalant Panel	84504	FDA UDI	Class II	Active
CLA® Allergen-Specific IgE Assay - Northwestern Inhalant Panel	84505	FDA UDI	Class II	Unknown
AP 720S™ Semi-Automated Processor	93602	FDA UDI	Class II	Active
OPTIGEN® AP 3600™ Automated Instrument	95413	FDA UDI	Class II	Active
OPTIGEN® Allergen-Specific IgE Assay - Universal 20 Panel	85003	FDA UDI	Class II	Unknown
CLA® Allergen-Specific IgE Assay - Western Inhalant Panel	84511	FDA UDI	Class II	Unknown
OPTIGEN® Allergen-Specific IgE Assay - US Food 30 (100ND)	85267	FDA UDI	Class II	Active
OPTIGEN® Allergen-Specific IgE Assay - US Food 25 (100 ND)	85082	FDA UDI	Class II	Active
OPTIGEN® Allergen-Specific IgE Assay - US Mix 36 Panel	85065	FDA UDI	Class II	Active
OPTIGEN® Allergen-Specific IgE Assay - US Environmental 36 (40ND)	85168	FDA UDI	Class II	Active
OPTIGEN® Positive Control Reagent	82061	FDA UDI	Class II	Active
OPTIGEN® Allergen-Specific IgE Assay - Environmental 36 (20T)	85068	FDA UDI	Class II	Active
OPTIGEN® Allergen-Specific IgE Assay - US Environmental 36 (100ND)	85268	FDA UDI	Class II	Active
OPTIGEN® Allergen-Specific IgE Assay - US Inhalant 36 Panel	85063	FDA UDI	Class II	Active
OPTIGEN® Allergen-Specific IgE Assay - US Inhalant 36(100 ND)	85081	FDA UDI	Class II	Active
CLA-1™ Luminometer	95019	FDA UDI	Class II	Active
CLA® Positive Control Serum	93026	FDA UDI	Class II	Active
UP20 Positive Control Reagent	80107	FDA UDI	Class II	Unknown
OPTIGEN® Allergen-Specific IgE Assay - US Food 20 Panel	85064	FDA UDI	Class II	Active
CLA® Allergen-Specific IgE Assay - Moderate Food Panel	84518	FDA UDI	Class II	Active
OPTIGEN® Allergen-Specific IgE Assay - US Food 25 (100 ND)	85066	FDA UDI	Class II	Active
CLA® Allergen-Specific IgE Assay - Southwestern Inhalant Panel	84509	FDA UDI	Class II	Unknown

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