Catalog Number

425-300B

Brand Name

Monobind AccuBind FSH ELISA Kit - 192 Wells

Version/Model Number

425-300

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

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K972720

Product Code

CGJ

Product Code Name

RADIOIMMUNOASSAY, FOLLICLE-STIMULATING HORMONE

Public Device Record Key

5db2cde5-8836-4c04-8d5d-f239b54a0bab

Public Version Date

March 11, 2019

Public Version Number

1

DI Record Publish Date

February 11, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-