CRPhsWR (C
CAROLINA LIQUID CHEMISTRIES CORP.® CRP-W CONTROL SET CC049 - CC049
Device Description
A material which is used to verify the performance of an assay intended to be used for the quantitative measurement of glucose in a clinical specimen.
Environmental Conditions
- Opened vials are stable for 21 days when stored refrigerated at 2 to 8°C.
- Reagent is stable when stored at 2-8° C until expiration date
- 8.00
- 2.00
Device Sizes
- Total Volume: 3 Milliliter
- Kit contains 1 control 1, 1 control 2 and 1 package insert
Device Sterilization
Device Sterile: False
Sterilization Prior To Use: False
Sterilization Methods: No Data Available
Product Codes
Code: DCK
Device Name: C-Reactive Protein, Antigen, Antiserum, And Control
Device Class: 2
Physical State: N/A
Definition: N/A
Submission Type ID: 1
Review Panel: IM
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: 866.5270
Third Party Flag: Y
Medical Specialty: IM
Code: JIS
Device Name: Calibrator, Primary
Device Class: 2
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: 862.1150
Third Party Flag: N
Medical Specialty: CH
Device IdentifiersDevice Id: 00817302022100
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