HAEMATOLOGY CONTROL - LEVEL 1 (HAEM CNTL - LEVEL 1)

HAEMATOLOGY CONTROL - LEVEL 1 (HAEM CNTL - LEVEL 1) - HM10190

A collection of reagent red blood cells and/or immunoglobulins directed at red blood cell antigens that are supplied together and intended to be used when testing a clinical specimen to verify the performance of multiple immunohaematological tests.

No Data Available

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: 05055273215618

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