Pointe Scientific, Inc. CMV IgG Reagent is for the detection of human IgG antibodies to cytomegalovirus virus in human serum by enzyme immunoassay, as an aid in the determination of acute or reactivated infection with CMV. When used as a qualitative test, CMV IgG EIA aids in the assessment of the patient's immunological response to CMV. These reagents have not received FDA clearance for use in testing blood or plasma donors. 96 tests

Pointe Scientific, Inc. CMV IgG Reagent is for the detection of human IgG antibodies to cytomegalovirus virus in human serum by enzyme immunoassay, as an aid in the determination of acute or reactivated infection with CMV. When used as a qualitative test, CMV IgG EIA aids in the assessment of the patient's immunological response to CMV. These reagents have not received FDA clearance for use in testing blood or plasma donors. 96 tests
Pointe Scientific, Inc. CMV IgG - T8005-96

A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of immunoglobulin G (IgG) antibodies to cytomegalovirus (CMV) in a clinical specimen, using an enzyme immunoassay (EIA) method.

No Data Available

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: LFZ

Device Name: Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus

Device Class: 2

Physical State: N/A

Definition: N/A

Submission Type ID: 1

Review Panel: MI

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: 866.3175

Third Party Flag: N

Medical Specialty: MI

Device Id: 00811727015198

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