ClearChem Diagnostics Inc. MicroProtein, Total - In Vitro Diagnostics testing kit R1:4X60mL, STD - CLEARCHEM DIAGNOSTICS INC.

Duns Number:010655581

Device Description: In Vitro Diagnostics testing kit R1:4X60mL, STD 1X15mL

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More Product Details

Catalog Number

MPN2020

Brand Name

ClearChem Diagnostics Inc. MicroProtein, Total

Version/Model Number

MPN2020

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)

-

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

JGP

Product Code Name

LOWRY (COLORIMETRIC), TOTAL PROTEIN

Device Record Status

Public Device Record Key

a8b5d200-27d7-4902-8a6a-06f959b33ce6

Public Version Date

July 09, 2018

Public Version Number

1

DI Record Publish Date

June 08, 2018

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"CLEARCHEM DIAGNOSTICS INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 11
2 A medical device with a moderate to high risk that requires special controls. 18