Ortho 7% BSA (12 ML)
ORTHO - 6986722
Device Description
A substance or reactant that is a bovine serum albumin (BSA) solution intended to be used in immunohaematological testing of a clinical specimen to enhance or potentiate red cell agglutination reactions by reducing the zeta potential of red blood cells.
Environmental Conditions
- -18.00
- -18.00
Device Sizes
No Data Available
Device Sterilization
Device Sterile: False
Sterilization Prior To Use: False
Sterilization Methods: No Data Available
Product Codes
Code: PPM
Device Name: General Purpose Reagent
Device Class: 1
Physical State: N/A
Definition: A general purpose reagent is a chemical reagent that has general laboratory application, that is used to collect, prepare, and examine specimens from the human body for diagnostic purposes, and that is not labeled or otherwise intended for a specific diagnostic application. It may be either an individual substance, or multiple substances reformulated, which, when combined with or used in conjunction with an appropriate analyte specific reagent (ASR) and other general purpose reagents, is part of a diagnostic test procedure or system constituting a finished in vitro diagnostic (IVD) test.
Submission Type ID: 4
Review Panel: PA
Review Code: N/A
Technical Method: Y
Gmp Exempt Flag: N/A
Life Sustain Support Flag: N
Unclassified Reason: N/A
Implant Flag: N
Target Area: Diagnostic
Regulation Number: 864.4010
Third Party Flag: N
Medical Specialty: PA
Device IdentifiersDevice Id: 20758750030900
Device Type: Package
DeviceId Issuing Agency: GS1
Contains DI Number: 10758750030903
Package Quantity: 24
Package Discontinue Date: N/A
Package Status: In Commercial Distribution
Package Type: Case
Device Id: 10758750030903
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