QuikCoag Calcium Choride 0.02M - Biomedica Diagnostics Inc

Duns Number:200152713

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More Product Details

Catalog Number

-

Brand Name

QuikCoag Calcium Choride 0.02M

Version/Model Number

10 mL

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

K022021,K022021

Product Code Details

Product Code

GFO

Product Code Name

Activated Partial Thromboplastin

Device Record Status

Public Device Record Key

4a020f2c-2843-437f-9e8f-188701c1f7c9

Public Version Date

February 24, 2020

Public Version Number

3

DI Record Publish Date

September 22, 2016

Additional Identifiers

Package DI Number

10627944000100

Quantity per Package

10

Contains DI Package

00627944000103

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box

"BIOMEDICA DIAGNOSTICS INC" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 8