For the quantitative determination of total thyroxine (T4) concentration in human serum. The test is useful in the diagnosis and treatment of thyroid disorders.
Total Thyroxine (T4) ELISA - EIA-1781
Device Description
A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of multiple thyroid markers associated with thyroid disease in a clinical specimen using an enzyme immunoassay (EIA) method. Analytes detected may include, but are not limited to, free triiodothyronine (FT3), free thyroxine (FT4), thyroid stimulating hormone (TSH) and/or thyroid peroxidase (TPO).
Environmental Conditions
- 8.00
- 2.00
Device Sizes
- Conjugate Diluent
- Total Volume: 11 Milliliter
- TMB
- Stop Solution
- Standards
- Total Volume: 13 Milliliter
- Conjugate Concentrate
- Total Volume: 1.3 Milliliter
- Total Volume: 1 Milliliter
Device Sterilization
Device Sterile: False
Sterilization Prior To Use: False
Sterilization Methods: No Data Available
Product Codes
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 IdentifiersDevice Id: 00840239017819
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