Catalog Number

-

Brand Name

ST AIA-PACK SHBG CALIBRATOR SET

Version/Model Number

N/A

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

-

Product Code

JIT

Product Code Name

Calibrator, Secondary

Public Device Record Key

d85e6dec-9599-4242-8feb-28a731914b13

Public Version Date

September 10, 2019

Public Version Number

1

DI Record Publish Date

September 02, 2019

Package DI Number

14560189213361

Quantity per Package

6

Contains DI Package

04560189213364

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-