The DRG Rheumatoid Factor (RF) IgM ELISA test system is intended for the qualitative and semi-quantitative detection of RF IgM-class antibody in human sera. The test system is intended to be used as an aid in the diagnosis of rheumatoid arthritis.

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

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