HCY (Homocysteine) Level 1 control 6 x 5 mL
CAROLINA LIQUID CHEMISTRIES CORP.® HCY LEVEL 1 CONTROL KIT PART# CC051 - CC051
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 homocysteine in a clinical specimen.
Environmental Conditions
- Controls are stable if refrigerated (2 to 8 °) until the date of expiration
- 8.00
- 2.00
Device Sizes
- Total Volume: 5 Milliliter
- Kit contains 6 control bottles and 1 package insert
Device Sterilization
Device Sterile: False
Sterilization Prior To Use: False
Sterilization Methods: No Data Available
Product Codes
Code: LPS
Device Name: Urinary Homocystine (Nonquantitative) Test System
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: 862.1377
Third Party Flag: Y
Medical Specialty: CH
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
Device IdentifiersDevice Id: 00817302020090
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