CREA (Creatinine) 4 x 400 tests
CAROLINA LIQUID CHEMISTRIES CORP.® CREA REAGENT PRODUCT NO. DT243 - DT243
Device Description
A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of creatine in a clinical specimen, using a spectrophotometry method.
Environmental Conditions
- Unopened reagents are stable to expiration date with stored at 2 to 8°C
- 30.00
- 8.00
Device Sizes
- Total Volume: 20 Milliliter
- Total Volume: 58 Milliliter
- Kit contains 4 R1 bottles, 4 R2 bottles and 1 package insert
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: JFY
Device Name: Enzymatic Method, Creatinine
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: 862.1225
Third Party Flag: Y
Medical Specialty: CH
Device IdentifiersDevice Id: 00817302023046
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