Procalcitonin (PCT) QC Kit Atellica IM
Atellica IM PCT QC - 10995652
Device Description
A material which is used to verify the performance of an assay intended to be used for the quantitative measurement of procalcitonin (PCT) in a clinical specimen.
Environmental Conditions
- Store Upright, Protect from Light, Do not freeze, Resuspend.
- 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: NTM
Device Name: Antigen, Inflammatory Response Marker, Sepsis
Device Class: 2
Physical State: N/A
Definition: An immunoluminometric assay used to determine the concentration of procalcitonin (pct) in human serum and plasma.
Submission Type ID: 1
Review Panel: MI
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: 866.3210
Third Party Flag: N
Medical Specialty: MI
Device IdentifiersDevice Id: 00630414599700
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