Amylase Flex® reagent cartridge, 240 tests
Dimension® Flex® reagent cartridge AMY - 10444965
Device Description
A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of total amylase in a clinical specimen, using a 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: JFJ
Device Name: Catalytic Methods, Amylase
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: 862.1070
Third Party Flag: Y
Medical Specialty: CH
Device IdentifiersDevice Id: 00842768005404
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
Device Id: 00630414004471
Device Type: Unit of Use
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