VITROS Chemistry Products RF Reagent
VITROS - 6801729
Device Description
A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of rheumatoid factor immunoglobulins in a clinical specimen, using an agglutination method.
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: DHR
Device Name: System, Test, Rheumatoid Factor
Device Class: 2
Physical State: N/A
Definition: N/A
Submission Type ID: 1
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: 866.5775
Third Party Flag: Y
Medical Specialty: IM
Device IdentifiersDevice Id: 10758750006809
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: 20758750006806
Device Type: Package
DeviceId Issuing Agency: GS1
Contains DI Number: 10758750006809
Package Quantity: 36
Package Discontinue Date: N/A
Package Status: In Commercial Distribution
Package Type: Case