The Quantitative Determination of Total Thyroxine Concentration in Human Serum or Plasma by a Microplate Enzyme Immunoassay

The Quantitative Determination of Total Thyroxine Concentration in Human Serum or Plasma by a Microplate Enzyme Immunoassay
21-Hydroxylase Autoantibody ELISA - EIA-5955

A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of antibodies to the adrenal gland 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: PCG

Device Name: 21-Hydroxylase Antibody (21-Ohab)

Device Class: 2

Physical State: RIA Assay Kit with reagents, antigen with I-125, calibrators, controls and assay buffer.

Definition: For semi-quantitative determination of antibodies to steroid 21-hydroxylase (21-OH) in human serum. The assay may be useful as an aid in the diagnosis of autoimmune adrenal disease, whether expressed as autoimmune Addison's disease (isolated) or Addison's disease as part of more complex autoimmune polyglandular syndrome (APS), type I or II. The assay result is to be used in conjunction with other clinical and laboratory findings and is not a substitute for functional testing required to diagnose adrenal insufficiency.

Submission Type ID: 1

Review Panel: IM

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: RIA

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: None

Regulation Number: 866.5660

Third Party Flag: Y

Medical Specialty: IM

Device Id: 00840239059550

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