Camco - Camco Stain Pak - A three step staining system - CAMBRIDGE DIAGNOSTIC PRODUCTS INC

Duns Number:069146876

Device Description: Camco Stain Pak - A three step staining system approximating results obtained from either Camco Stain Pak - A three step staining system approximating results obtained from either Wright or Wright-Giemsa Stain.

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More Product Details

Catalog Number

702

Brand Name

Camco

Version/Model Number

702

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)

-

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

KQC

Product Code Name

Stains, Hematology

Device Record Status

Public Device Record Key

0c8e72d5-43c1-4e78-a746-82c1131bfa58

Public Version Date

March 11, 2019

Public Version Number

3

DI Record Publish Date

March 10, 2017

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"CAMBRIDGE DIAGNOSTIC PRODUCTS INC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 12
2 A medical device with a moderate to high risk that requires special controls. 2