ImmunoCAP Rare Allergen Rf340, Cochineal extract (Carmine red) - ImmunoCAP Rare Allergen Rf340, Cochineal extract - Phadia AB

Duns Number:354019424

Device Description: ImmunoCAP Rare Allergen Rf340, Cochineal extract (Carmine red)

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More Product Details

Catalog Number

14-5268-10

Brand Name

ImmunoCAP Rare Allergen Rf340, Cochineal extract (Carmine red)

Version/Model Number

14-5268-10

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

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

-

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

-

Product Code Details

Product Code

MVU

Product Code Name

Reagents, specific, analyte

Device Record Status

Public Device Record Key

f232de59-a001-4078-b505-86f76fd1e524

Public Version Date

June 10, 2022

Public Version Number

2

DI Record Publish Date

April 30, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"PHADIA AB" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 225
2 A medical device with a moderate to high risk that requires special controls. 518