Panoscreen EXTEND is intended for use in the detection of unexpected red blood cell blood group antibodies.

Panoscreen EXTEND is intended for use in the detection of unexpected red blood cell blood group antibodies.
Panoscreen EXTEND - 0002383

A collection of four or more specifically characterized reagent red blood cells that are supplied together as a set and intended to be used to determine the exact specificity of antibodies to red blood cell antigens present in a clinical specimen, using an agglutination method.

No Data Available

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: QHT

Device Name: Reagent Red Blood Cells

Device Class: U

Physical State: Sourced from human blood

Definition: For the detection of or identification of human blood-group antibodies

Submission Type ID: 3

Review Panel: HE

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: Antigen and antibody reaction by hemagglutination, column agglutination (gel technique), solid phase or microplate

Life Sustain Support Flag: N

Unclassified Reason: 1

Implant Flag: N

Target Area: Serum or plasma

Regulation Number: 660.30

Third Party Flag: N

Medical Specialty: HE

Device Id: 10888234002406

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