T4 for the quantitative determination of the Total Thyroxine (T4) concentration in human serum. For in vitro diagnostic use only. 96 Test

T4 for the quantitative determination of the Total Thyroxine (T4) concentration in human serum. For in vitro diagnostic use only. 96 Test
Pointe Scientific, Inc. - T1007-96

A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of the unbound/free portion of multiple proteins [e.g., thyroxine binding globulin (TBG), transthyretin and/or albumin] associated with thyroid hormone uptake, using a radioimmunoassay method. It is typically used to aid in the assessment of thyroid hormone binding capacity for the diagnosis of thyroid disorders associated with hypothyroidism or hyperthyroidism.

No Data Available

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: KLI

Device Name: Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine

Device Class: 2

Physical State: N/A

Definition: N/A

Submission Type ID: 4

Review Panel: CH

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: 862.1700

Third Party Flag: N

Medical Specialty: CH

Device Id: 00811727013149

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