MTS - MTS A/B/D Monoclonal Grouping Card - MICRO TYPING SYSTEMS, INC

Duns Number:781421888

Device Description: MTS A/B/D Monoclonal Grouping Card

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More Product Details

Catalog Number

MTS081115

Brand Name

MTS

Version/Model Number

MTS081115

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)

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

-

Product Code Name

-

Device Record Status

Public Device Record Key

cf72e356-6f9d-408b-915b-c9b004c79e74

Public Version Date

October 24, 2022

Public Version Number

6

DI Record Publish Date

October 22, 2014

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"MICRO TYPING SYSTEMS, INC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 5
2 A medical device with a moderate to high risk that requires special controls. 5