Trinity Biotech - Captia™ EBV VCA IgM - CLARK LABORATORIES, INC.

Duns Number:623214079

Device Description: Captia™ EBV VCA IgM

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More Product Details

Catalog Number

2325760

Brand Name

Trinity Biotech

Version/Model Number

2325760

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K980596

Product Code Details

Product Code

LSE

Product Code Name

Epstein-Barr Virus, Other

Device Record Status

Public Device Record Key

85be80e0-5dc6-4443-a2f5-251353eb026c

Public Version Date

November 04, 2019

Public Version Number

1

DI Record Publish Date

October 25, 2019

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"CLARK LABORATORIES, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 50
2 A medical device with a moderate to high risk that requires special controls. 116