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.


Product Overview

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 Identifiers

Device 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


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