DS5 HbA1c Control (2-level) (2 x 3 x 0.5mL)

DS5 HbA1c Control (2
Drew Scientific - 014-175SA

A collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative determination of the prothrombin time (PT) of a clinical specimen, with or without standardization to the international normalized ratio (INR), within a short period relative to standard laboratory testing procedures using a clotting method. This is a rapid test commonly used in the laboratory or in point-of-care analyses. It is not intended to be used for self-testing.

No Data Available

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: JPK

Device Name: Mixture, Hematology Quality Control

Device Class: 2

Physical State: N/A

Definition: N/A

Submission Type ID: 4

Review Panel: HE

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: N/A

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: N/A

Regulation Number: 864.8625

Third Party Flag: N

Medical Specialty: HE

Device Id: 00817274020159

Device Type: Primary

DeviceId Issuing Agency: GS1

Contains DI Number: N/A

Package Quantity: N/A

Package Discontinue Date: N/A

Package Status: N/A

Package Type: N/A