For the calibration of the K
K-ASSAY® D-Dimer Calibrator - KAI-091C
Device Description
A material which is used to establish known points of reference for an assay intended to be used for the qualitative and/or quantitative detection of D-dimer protein in a clinical specimen.
Environmental Conditions
- 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: GHH
Device Name: Fibrin Split Products
Device Class: 2
Physical State: N/A
Definition: N/A
Submission Type ID: 1
Review Panel: HE
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: 864.7320
Third Party Flag: Y
Medical Specialty: HE
Device Identifiers
Device Id: 00816426020665
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
