For the quantitative determination of thyroid stimulating hormone (TSH) concentration in human serum. The assay is useful in the diagnosis of thyroid or pituitary disorders.
Thyroid Stimulating Hormone (TSH) ELISA - EIA-1782
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
No Data Available
Device Sizes
- Total Volume: 13 Milliliter
- Conjugate Reagent
- Stop Solution
- Standards
- Total Volume: 1 Milliliter
- TMB Reagent
- Total Volume: 11 Milliliter
Device Sterilization
Device Sterile: False
Sterilization Prior To Use: False
Sterilization Methods: No Data Available
Product Codes
Code: JLW
Device Name: Radioimmunoassay, Thyroid-Stimulating Hormone
Device Class: 2
Physical State: N/A
Definition: N/A
Submission Type ID: 1
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: 862.1690
Third Party Flag: Y
Medical Specialty: CH
Device IdentifiersDevice Id: 00840239017826
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