Catalog Number

PRD-05075

Brand Name

APTIMA

Version/Model Number

CMV, CALIBRATOR KIT, APTIMA, IVD

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

P210029

Product Code

PAB

Product Code Name

Cytomegalovirus (cmv) dna quantitative assay

Public Device Record Key

5fa9da52-ad49-4250-a029-30e775ecf3f4

Public Version Date

June 09, 2022

Public Version Number

1

DI Record Publish Date

June 01, 2022

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-