TSH for the quantitative determination of the thyroid stimulating hormone (TSH) concentration in human serum. The assay is useful in the diagnosis of thyroid or pituitary disorders. For in vitro diagnostic use only. 96 Tests.
Pointe Scientific, Inc. - T1001-96
Device Description
A collection of reagents and other associated materials intended to be used for the quantitative measurement of thyroid stimulating hormone (TSH) in a clinical specimen, using an enzyme immunoassay (EIA) method.
Environmental Conditions
- 8.00
- 2.00
Device Sizes
No Data Available
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: 00811727013170
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