Quantitative determination of albumin in human serum, plasma, urine and CSF on BN Systems
N Antiserum to Human Albumin - 10714508
Device Description
A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of albumin in a clinical specimen, using a nephelometry/turbidimetry method. It is typically used to aid in the diagnosis and monitoring of diseases affecting protein metabolism (e.g., liver disease, kidney disease, severe malnutrition, malabsorption, burns).
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: 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
Device IdentifiersDevice Id: 00842768038013
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