The DRG Rheumatoid Factor (RF) IgM ELISA test system is intended for the qualitative and semi
RF IgM (Rheumatoid Factor) ELISA - EIA-2775
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 enzyme immunoassay (EIA) method.
Environmental Conditions
No Data Available
Device Sizes
- Conjugate
- Stop Solution
- Total Volume: 100 Milliliter
- Calibrators
- Negative Control
- Sample Diluent
- Positive Control
- Total Volume: 30 Milliliter
- Total Volume: 0.35 Milliliter
- Wash Buffer
- Total Volume: 0.5 Milliliter
- TMB Substrate Solution
- Total Volume: 15 Milliliter
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 Identifiers
Device Id: 00840239027757
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
