The BNP Controls for Abbott (CQ10521) are intended for use with in vitro diagnostic assays for the quantitative determination of BNP in human serum and plasma. The BNP Controls for Abbott (CQ10521) are assayed with target values and are suitable for use on Abbott analysers. The BNP Controls for Abbott (CQ10521) are for use by trained
laboratory professionals and can be used in determining the precision of testing systems and in identifying sources of variation.
BNP CONTROLS FOR ABBOTT (BNP CONTROL) - CQ10521
Device Description
A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of B-type natriuretic protein (BNP) and/or N-terminal pro b-type natriuretic peptide (NT-proBNP) in a clinical specimen.
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: 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
Device Identifiers
Device Id: 05055273218497
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