The PTH (Parathyroid) Intact ELISA is intended for the quantitative determination of Intact
PTH (Parathyroid) Intact ELISA - EIA-3645
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 an enzyme immunoassay (EIA) method.
Environmental Conditions
No Data Available
Device Sizes
- Sample Diluent
- Reconstitution Solution
- TMB Substrate
- Stop Solution
- Controls 1 & 2
- Calibrators
- Biotinylated Antibody Solution
- Enzyme Antibody Solution
- Wash Concentrate
- Total Volume: 7 Milliliter
- Total Volume: 2 Milliliter
- Total Volume: 5 Milliliter
- Total Volume: 30 Milliliter
- Total Volume: 0.5 Milliliter
- Total Volume: 20 Milliliter
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: 00840239036452
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