- Physicians Office Resource

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

Device Description

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.

Environmental Conditions

Storage Environment Temperature - Degrees Celsius

10.00
1.00

Device Sizes

No Data Available

Device Sterilization

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Product Codes

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 Identifiers

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

GMDN® is a registered trademark of The GMDN Agency. All rights reserved. The information provided on this site includes data supplied by The GMDN Agency ("GMDN Content"), which is used under licence from The GMDN Agency. Any data/information suppliers who wish to extract GMDN Content from this site in order to use it as a basis for creating and supporting commercial services such as alternative categorisation, alternative GMDN Term assignment, mapping to other categorisations or ontologies, or for AI training purposes, must first obtain an appropriate licence from The GMDN Agency. No such activity is permitted without a licence. For more information on obtaining a licence, please contact The GMDN Agency (https://www.gmdnagency.org/contact-us/). None of the GMDN content constitutes any endorsement, advice, representation or warranty about any specific medical devices that may be described by such content; and no representation or warranty is made in relation to instructions for use, suitability for any application, treatment or condition, regulatory status, or any properties of a particular medical device.