Monobind AccuBind Folate ELISA Kit - 192 Wells - MONOBIND, INC.

Duns Number:083155515

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More Product Details

Catalog Number

7525-300B

Brand Name

Monobind AccuBind Folate ELISA Kit - 192 Wells

Version/Model Number

7525-300

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

-

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

CGN

Product Code Name

ACID, FOLIC, RADIOIMMUNOASSAY

Device Record Status

Public Device Record Key

9c133df7-b471-4930-b4ee-b4ed0b4c419e

Public Version Date

March 11, 2019

Public Version Number

1

DI Record Publish Date

February 11, 2019

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"MONOBIND, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 94
2 A medical device with a moderate to high risk that requires special controls. 204