CLA® Allergen-Specific IgE Assay - Northwestern Inhalant Panel - KIT, Northwestern Inhalant - Minaris Medical America, Inc.

Duns Number:102113867

Device Description: KIT, Northwestern Inhalant

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More Product Details

Catalog Number

84505

Brand Name

CLA® Allergen-Specific IgE Assay - Northwestern Inhalant Panel

Version/Model Number

84505

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

March 09, 2021

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K823593,K833885,K834526,K843694,K926420,K934524

Product Code Details

Product Code

DHB

Product Code Name

SYSTEM, TEST, RADIOALLERGOSORBENT (RAST) IMMUNOLOGICAL

Device Record Status

Public Device Record Key

2e2703e3-31ad-4ee1-b310-fd4f0a3eae01

Public Version Date

June 10, 2022

Public Version Number

6

DI Record Publish Date

August 19, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"MINARIS MEDICAL AMERICA, INC." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 27