ST AIA-PACK PRL - TOSOH CORPORATION

Duns Number:690571724

Want to know more about this Product? Request more information now!


More Product Details

Catalog Number

-

Brand Name

ST AIA-PACK PRL

Version/Model Number

N/A

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)

-

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

CFT

Product Code Name

Radioimmunoassay, Prolactin (Lactogen)

Device Record Status

Public Device Record Key

2a25fa93-08fc-45bf-bb0e-97d92437fdc6

Public Version Date

August 02, 2019

Public Version Number

1

DI Record Publish Date

July 25, 2019

Additional Identifiers

Package DI Number

24560189210831

Quantity per Package

10

Contains DI Package

14560189210834

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-

"TOSOH CORPORATION" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 40
2 A medical device with a moderate to high risk that requires special controls. 95