Quality Club EliA Autoimmunity - Contains four different single-use vials with - Phadia AB

Duns Number:354019424

Device Description: Contains four different single-use vials with control samples, one vial for each month of Contains four different single-use vials with control samples, one vial for each month of a four months period.

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More Product Details

Catalog Number

83-1006-01

Brand Name

Quality Club EliA Autoimmunity

Version/Model Number

83-1006-01

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

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

-

Product Code Details

Product Code

OHQ

Product Code Name

Multi-analyte controls unassayed

Device Record Status

Public Device Record Key

c55be60e-0905-4640-8073-f63754bfec6f

Public Version Date

August 02, 2019

Public Version Number

1

DI Record Publish Date

July 25, 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