Vitamin D
CAROLINA LIQUID CHEMISTRIES CORP.® CLC720 Vitamin D RGT KIT Product No. ST500 - ST501
Device Description
A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of multiple forms of 25-hydroxy vitamin D in a clinical specimen.
Environmental Conditions
- Reagent is stable on board a clinical analyzer for 30 days when stored at 2 to 8°C
- Unopened reagents are stable to expiration date when stored at 2 to 8°C
- 8.00
- 2.00
Device Sizes
- Kit contains 2 Control 1 bottles, 2 Control 2 bottles and 1 package insert
- Total Volume: 2 Milliliter
Device Sterilization
Device Sterile: False
Sterilization Prior To Use: False
Sterilization Methods: No Data Available
Product Codes
Code: JJX
Device Name: Single (Specified) Analyte Controls (Assayed And Unassayed)
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: 862.1660
Third Party Flag: N
Medical Specialty: CH
Code: MRG
Device Name: System, Test, Vitamin D
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: 862.1825
Third Party Flag: Y
Medical Specialty: CH
Device IdentifiersDevice Id: 00817302020168
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