FITC Quality Control Slide ™ - FITC Quality Control Slide - IMMUNO CONCEPTS INC

Duns Number:038271904

Device Description: FITC Quality Control Slide

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More Product Details

Catalog Number

1900 (1)

Brand Name

FITC Quality Control Slide ™

Version/Model Number

1900 (1)

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

-

Product Code Name

-

Device Record Status

Public Device Record Key

dc9cf3da-13cd-4013-bf66-f4501c7386c3

Public Version Date

May 10, 2021

Public Version Number

3

DI Record Publish Date

January 10, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"IMMUNO CONCEPTS INC" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 2