ImmunoCAP Specific IgA Curve Controls - Contains three vials of each Specific IgA Curve - Phadia AB

Duns Number:354019424

Device Description: Contains three vials of each Specific IgA Curve Control (CC-1, CC-2) for the ImmunoCAP Spe Contains three vials of each Specific IgA Curve Control (CC-1, CC-2) for the ImmunoCAP Specific IgA method.

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More Product Details

Catalog Number

10-9308-01

Brand Name

ImmunoCAP Specific IgA Curve Controls

Version/Model Number

10-9308-01

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

K052793

Product Code Details

Product Code

MST

Product Code Name

Antibodies, gliadin

Device Record Status

Public Device Record Key

2de33bcf-4783-4bff-bbb4-50dd79bb09c3

Public Version Date

April 03, 2019

Public Version Number

1

DI Record Publish Date

March 26, 2019

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