Whole Blood Matrix - MORE DIAGNOSTICS Whole Blood Matrix is intended - MORE DIAGNOSTICS INC

Duns Number:829978451

Device Description: MORE DIAGNOSTICS Whole Blood Matrix is intended to be used as a whole blood matrix and zer

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More Product Details

Catalog Number

375-B

Brand Name

Whole Blood Matrix

Version/Model Number

375-B

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

Yes

Prescription Use (Rx)

Yes

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

JJY

Product Code Name

Multi-Analyte Controls, All Kinds (Assayed)

Device Record Status

Public Device Record Key

7b3171be-2ecc-4921-8d13-8885eea7dc83

Public Version Date

June 25, 2020

Public Version Number

1

DI Record Publish Date

June 17, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"MORE DIAGNOSTICS INC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 28