Monobind AccuLite cTnI CLIA Kit - 96 Wells - MONOBIND, INC.

Duns Number:083155515

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More Product Details

Catalog Number

3875-300A

Brand Name

Monobind AccuLite cTnI CLIA Kit - 96 Wells

Version/Model Number

3875-300

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

MMI

Product Code Name

IMMUNOASSAY METHOD, TROPONIN SUBUNIT

Device Record Status

Public Device Record Key

6cd95d30-9e7e-4e11-b317-7d62968a2746

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