APTIMA

APTIMA - CMV, CALIBRATOR KIT, APTIMA, IVD

An externally applied orthopaedic appliance or apparatus designed to encompass the elbow joint, the wrist joint, and the whole or part of the hand to support, correct, or improve function of the elbow, wrist, and hand through actions such as alignment, hinge-support, or dorsiflexion assistance. This is a reusable device.

No Data Available

No Data Available

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: PAB

Device Name: Cytomegalovirus (Cmv) Dna Quantitative Assay

Device Class: 3

Physical State: IVD

Definition: Cytomegalovirus (CMV) DNA Quantitative Assay is an in vitro nucleic acid assay for the quantitative measurement of CMV DNA in human plasma or whole blood. The assay can be used to measure CMV DNA levels serially at baseline and during the course of antiviral treatment to assess virological response to treatment. The test results must be interpreted within the context of all relevant clinical and laboratory findings.

Submission Type ID: 2

Review Panel: MI

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: In vitro nucleic acid based assay using real-time PCR for the quantitative measurement of CMV DNA

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: Not Applicable

Regulation Number: N/A

Third Party Flag: N

Medical Specialty: N/A

Device Id: 15420045514577

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