Para 12 Extend - A Multi-Parameter Assayed Hematology Control for - STRECK, INC.

Duns Number:072915986

Device Description: A Multi-Parameter Assayed Hematology Control for Instruments Offering a 3-Part Differentia A Multi-Parameter Assayed Hematology Control for Instruments Offering a 3-Part Differential. Contains 1 vial of normal level.

Want to know more about this Product? Request more information now!


More Product Details

Catalog Number

218752

Brand Name

Para 12 Extend

Version/Model Number

218752

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

K823498

Product Code Details

Product Code

GLQ

Product Code Name

Mixture, Control, White-Cell And Red-Cell Indices

Device Record Status

Public Device Record Key

cdd7e3f5-a974-4060-adfe-f375aecfdef8

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 14, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"STRECK, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 30
2 A medical device with a moderate to high risk that requires special controls. 136