Reagent Red Blood Cells (Pooled Cells) Ortho® Coombs Control

Reagent Red Blood Cells (Pooled Cells) Ortho® Coombs Control
ORTHO - 719810

A sample of reagent red blood cells sensitized to or coated with antibodies [e.g., immunoglobulin G (IgG) or immunoglobulin M (IgM)] intended to be used to verify the performance of an assay (e.g., Coombs control) for evaluation of a clinical specimen.

No Data Available

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: KSF

Device Name: Kit, Quality Control For Blood Banking Reagents

Device Class: 2

Physical State: N/A

Definition: N/A

Submission Type ID: 1

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: 864.9650

Third Party Flag: N

Medical Specialty: HE

Device Id: 10758750004072

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