BNP Cartridge
i-STAT - 03P93-25
Device Description
A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is 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
- 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: NBC
Device Name: Test, Natriuretic Peptide
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: 862.1117
Third Party Flag: N
Medical Specialty: CH
Device IdentifiersDevice Id: 10054749000217
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: 00054749000210
Device Type: Package
DeviceId Issuing Agency: GS1
Contains DI Number: 10054749000217
Package Quantity: 25
Package Discontinue Date: N/A
Package Status: In Commercial Distribution
Package Type: Case