The Access Intact PTH assay is a paramagnetic particle, chemiluminescent immunoassay fir the quantitative determination of intact parathyroid hormone (parathyin, PTH) levels in human serum and plasma using the Access Immunoassay Systems.
Access Intact PTH - A16972
Device Description
A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of parathyroid hormone (PTH) [intact, whole, or truncated fragments] in a clinical specimen, using a chemiluminescent immunoassay method.
Environmental Conditions
No Data Available
Device Sizes
No Data Available
Device Sterilization
Device Sterile: False
Sterilization Prior To Use: False
Sterilization Methods: No Data Available
Product Codes
Code: CEW
Device Name: Radioimmunoassay, Parathyroid 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: 862.1545
Third Party Flag: Y
Medical Specialty: CH
Device IdentifiersDevice Id: 15099590201937
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