Monobind AccuLite T3 CLIA Kit - 480 Wells - MONOBIND, INC.

Duns Number:083155515

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More Product Details

Catalog Number

175-300D

Brand Name

Monobind AccuLite T3 CLIA Kit - 480 Wells

Version/Model Number

175-300

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

CDP

Product Code Name

RADIOIMMUNOASSAY, TOTAL TRIIODOTHYRONINE

Device Record Status

Public Device Record Key

89d158af-8abe-4a8e-8649-fdc630ee6c0d

Public Version Date

March 11, 2019

Public Version Number

1

DI Record Publish Date

February 27, 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