Minaris Medical America, Inc.

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

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Filters

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) (5) System, Test, Radioallergosorbent (Rast) Immunological, Exempt Allergens (PUW) (3) IGE, ANTIGEN, ANTISERUM, CONTROL (DGC) (2)

Premarket Exempt

No Yes

Clear

OPTIGEN® Allergen-Specific IgE Assay - Universal 20 Panel - 00813382010006 Catalog Number : 85003

Device Description : KIT, OPTIGEN Universal Panel 20

Device Class : 2

Duns Number: 102113867

Premarket Exempt : No

Product Code : DHB

Prescription Use : Yes

Device Count : 1

OPTIGEN® Allergen-Specific IgE Assay - Food 29 (20T) - 00813382010013 Catalog Number : 85067

Device Description : KIT, OPTIGEN® Food 29 (20T)

Device Class : 2

Duns Number: 102113867

Premarket Exempt : Yes

Product Code : PUW

Prescription Use : Yes

Device Count : 1

OPTIGEN® Allergen-Specific IgE Assay - US Food 30 (100ND) - 00813382010020 Catalog Number : 85267

Device Description : KIT, OPTIGEN US Food 30 (100ND)

Device Class : 2

Duns Number: 102113867

Premarket Exempt : Yes

Product Code : PUW

Prescription Use : Yes

Device Count : 1

OPTIGEN® Allergen-Specific IgE Assay - Environmental 36 (20T) - 00813382010037 Catalog Number : 85068

Device Description : KIT, OPTIGEN® Environmental 36 (20T)

Device Class : 2

Duns Number: 102113867

Premarket Exempt : Yes

Product Code : PUW

Prescription Use : Yes

Device Count : 1

CLA-1™ Luminometer - 00813382010044 Catalog Number : 95019

Device Description : CLA-1 Luminometer

Device Class : 2

Duns Number: 102113867

Premarket Exempt : No

Product Code : DHB

Prescription Use : Yes

Device Count : 1

OPTIGEN® Allergen-Specific IgE Assay - Universal 20 Panel - 00813382010075 Catalog Number : 85003

Device Description : KIT, OPTIGEN Universal Panel 20

Device Class : 2

Duns Number: 102113867

Premarket Exempt : No

Product Code : DHB

Prescription Use : Yes

Device Count : 1

OPTIGEN® Positive Control Reagent - 00813382010082 Catalog Number : 82061

Device Description : OPTIGEN Positive Control

Device Class :

Duns Number: 102113867

Premarket Exempt : No

Product Code : DGC

Prescription Use : Yes

Device Count : 3

OPTIGEN® Negative Control Reagent - 00813382010099 Catalog Number : 82062

Device Description : OPTIGEN Negative Control

Device Class :

Duns Number: 102113867

Premarket Exempt : No

Product Code : DGC

Prescription Use : Yes

Device Count : 3

CLA® Allergen-Specific IgE Assay - Eastern - 00813382010105 Catalog Number : 84502

Device Description : KIT, Eastern

Device Class : 2

Duns Number: 102113867

Premarket Exempt : No

Product Code : DHB

Prescription Use : Yes

Device Count : 1

CLA® Allergen-Specific IgE Assay - Northeastern Inhalant Panel - 00813382010112 Catalog Number : 84504

Device Description : KIT, Northeastern Inhalant

Device Class : 2

Duns Number: 102113867

Premarket Exempt : No

Product Code : DHB

Prescription Use : Yes

Device Count : 1

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