Minaris Medical America, Inc.

Address:630 CLYDE CT.,MOUNTAIN VIEW,CA,94043,US

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Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

SYSTEM, TEST, RADIOALLERGOSORBENT (RAST) IMMUNOLOGICAL (DHB) (8) System, test, radioallergosorbent (rast) immunological (DHB) (2)

Premarket Exempt

No Yes

Clear

CLA® Allergen-Specific IgE Assay - Northwestern Inhalant Panel - 00813382010129 Catalog Number : 84505

Device Description : KIT, Northwestern Inhalant

Device Class : 2

Duns Number: 102113867

Premarket Exempt : No

Product Code : DHB

Prescription Use : Yes

Device Count : 1

CLA® Allergen-Specific IgE Assay - Pediatric Comprehensive Panel - 00813382010136 Catalog Number : 84506

Device Description : KIT, Pediatric Comprehensive

Device Class : 2

Duns Number: 102113867

Premarket Exempt : No

Product Code : DHB

Prescription Use : Yes

Device Count : 1

CLA® Allergen-Specific IgE Assay - Southeastern Inhalant Panel - 00813382010143 Catalog Number : 84507

Device Description : KIT, Southeastern Inhalant

Device Class : 2

Duns Number: 102113867

Premarket Exempt : No

Product Code : DHB

Prescription Use : Yes

Device Count : 1

CLA® Allergen-Specific IgE Assay - Southwestern Inhalant Panel - 00813382010150 Catalog Number : 84509

Device Description : KIT, Southwestern Inhalant

Device Class : 2

Duns Number: 102113867

Premarket Exempt : No

Product Code : DHB

Prescription Use : Yes

Device Count : 1

CLA® Allergen-Specific IgE Assay - Western Inhalant Panel - 00813382010167 Catalog Number : 84511

Device Description : KIT, Western Inhalant

Device Class : 2

Duns Number: 102113867

Premarket Exempt : No

Product Code : DHB

Prescription Use : Yes

Device Count : 1

CLA® Allergen-Specific IgE Assay - Moderate Food Panel - 00813382010174 Catalog Number : 84518

Device Description : KIT, Moderate Food

Device Class : 2

Duns Number: 102113867

Premarket Exempt : No

Product Code : DHB

Prescription Use : Yes

Device Count : 1

CLA® Negative Control Serum - 00813382010181 Catalog Number : 94173

Device Description : CLA Neg Ctrl Serum

Device Class :

Duns Number: 102113867

Premarket Exempt : No

Product Code : DHB

Prescription Use : Yes

Device Count : 3

CLA® Positive Control Serum - 00813382010198 Catalog Number : 93026

Device Description : CLA Pos Ctrl Serum

Device Class :

Duns Number: 102113867

Premarket Exempt : No

Product Code : DHB

Prescription Use : Yes

Device Count : 3

OPTIGEN® AP 3600™ Automated Instrument - 00813382010204 Catalog Number : 95413

Device Description : Automated In Vitro Allergy Diagnostic System

Device Class : 2

Duns Number: 102113867

Premarket Exempt : No

Product Code : DHB

Prescription Use : Yes

Device Count : 1

AP 720S™ Semi-Automated Processor - 00813382010211 Catalog Number : 93602

Device Description : AP 720S™ Semi-Automated Processor

Device Class : 2

Duns Number: 102113867

Premarket Exempt : No

Product Code : DHB

Prescription Use : No

Device Count : 1

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