Sickle-Chex - A positive and negative whole blood control to - STRECK, INC.

Duns Number:072915986

Device Description: A positive and negative whole blood control to test for the presence of Hemoglobin S in so A positive and negative whole blood control to test for the presence of Hemoglobin S in solubility tests and hemoglobin electrophoresis. Contains 2 each of P+ & N-

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More Product Details

Catalog Number

217654

Brand Name

Sickle-Chex

Version/Model Number

217654

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

K013316

Product Code Details

Product Code

GHM

Product Code Name

Test, Sickle Cell

Device Record Status

Public Device Record Key

cb9d54ec-64eb-4dda-9d20-f82cf3ee161a

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 19, 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