PK7300

PK7300
PK7300 - N3209000

An electrically-powered automated or semi-automated laboratory instrument intended to be used to perform pre-transfusion blood group testing, red cell antibody screening/identification and/or red cell phenotyping of clinical specimens or donor specimens in order to determine suitability for transfusion or transplantation. Testing may include ABO, Rhesus or other red cell blood group systems and may use microplate-based serological methods, cassettes or column agglutinating technology.

No Data Available

No Data Available

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: KSZ

Device Name: System, Test, Automated Blood Grouping And Antibody

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: 864.9175

Third Party Flag: N

Medical Specialty: HE

Device Id: 14987666535721

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