Catalog Number

-

Brand Name

Scantibodies Laboratory, Inc.

Version/Model Number

3KG600

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

K004038

Product Code

CEW

Product Code Name

Radioimmunoassay, Parathyroid Hormone

Public Device Record Key

49aeb4f6-2a0b-4347-ad22-56c65faf893d

Public Version Date

December 23, 2019

Public Version Number

2

DI Record Publish Date

May 20, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-