MALB (Microalbumin) 2 x 100 tests
CAROLINA LIQUID CHEMISTRIES CORP.® MALB RGT. KIT AU-662 - AU-662
Device Description
A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of microalbumin in a clinical specimen, using a spectrophotometry method.
Environmental Conditions
- Reagent is stable when stored at 2-8° C until expiration date
- Reagent is stable on board a clinical analyzer for 30 days
- 8.00
- 2.00
Device Sizes
- Total Volume: 15 Milliliter
- Kit contains 3 R1, 2 R2 and 1 package insert
- Total Volume: 5 Milliliter
Device Sterilization
Device Sterile: False
Sterilization Prior To Use: False
Sterilization Methods: No Data Available
Product Codes
Code: DCF
Device Name: Albumin, Antigen, Antiserum, Control
Device Class: 2
Physical State: N/A
Definition: N/A
Submission Type ID: 4
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: 866.5040
Third Party Flag: N
Medical Specialty: IM
Code: JIT
Device Name: Calibrator, Secondary
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 Identifiers
Device Id: 00817302020960
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
