Pointe Creatinine Enzymatic Reagent packaged for use on the BS480. 4x40mL, 4x14mL Kit. For the quantitative enzymatic determination of creatinine in serum and urine. For In Vitro Diagnostic Use Only.
Pointe Creatinine Enzymatic on BS480 - 14-C7548-216
Device Description
A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of creatinine in a clinical specimen, using an enzyme spectrophotometry method.
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: 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: 00811727015761
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