VITROS Immunodiagnostic Products NTx Calibrators

VITROS Immunodiagnostic Products NTx Calibrators
VITROS - 6800031

A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of collagen type I cross-linked C-telopeptides and/or metabolites [e.g., beta-isomerized C-terminal telopeptide of type I collagen (beta-CTx)] in a clinical specimen, using a chemiluminescent immunoassay method. Collagen type I cross-linked C-telopeptide and metabolites are typically used to aid in the diagnosis of conditions associated with elevated bone lysis/resorption (e.g., multiple myeloma, osteolytic metastasis, osteoporosis, rheumatoid arthritis).

No Data Available

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: JMM

Device Name: Column Chromatography & Color Development, Hydroxyproline

Device Class: 1

Physical State: N/A

Definition: N/A

Submission Type ID: 4

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: 862.1400

Third Party Flag: N

Medical Specialty: CH

Device Id: 10758750000517

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

Device Id: 20758750000514

Device Type: Package

DeviceId Issuing Agency: GS1

Contains DI Number: 10758750000517

Package Quantity: 30

Package Discontinue Date: N/A

Package Status: In Commercial Distribution

Package Type: Case