MeDiCa - Rat Liver 8 Well Slide (each) - SCIMEDX CORPORATION

Duns Number:155424708

Device Description: Rat Liver 8 Well Slide (each)

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More Product Details

Catalog Number

0102

Brand Name

MeDiCa

Version/Model Number

0102

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

K782048

Product Code Details

Product Code

DHN

Product Code Name

Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control

Device Record Status

Public Device Record Key

19f5bc0f-9584-437e-b168-a13b369c30ec

Public Version Date

December 09, 2020

Public Version Number

1

DI Record Publish Date

December 01, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"SCIMEDX CORPORATION" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 27
2 A medical device with a moderate to high risk that requires special controls. 240