Platelia - EBV IgG/IgM Concentrated Washing Solution (20x) - CLARK LABORATORIES, INC.

Duns Number:623214079

Device Description: EBV IgG/IgM Concentrated Washing Solution (20x)

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More Product Details

Catalog Number

827102

Brand Name

Platelia

Version/Model Number

827102

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

87682c03-c40b-4973-b05f-3af711a8a116

Public Version Date

August 14, 2019

Public Version Number

1

DI Record Publish Date

August 06, 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