PathoDX Adenovirus Reagent - REMEL EUROPE LIMITED

Duns Number:232600853

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More Product Details

Catalog Number

-

Brand Name

PathoDX Adenovirus Reagent

Version/Model Number

R62407

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

K983336

Product Code Details

Product Code

LKT

Product Code Name

Respiratory Syncytial Virus, Antigen, Antibody, Ifa

Device Record Status

Public Device Record Key

322e8ca7-49d2-4492-b676-7cb37f79f3a8

Public Version Date

July 29, 2021

Public Version Number

1

DI Record Publish Date

July 21, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"REMEL EUROPE LIMITED" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 67
2 A medical device with a moderate to high risk that requires special controls. 124