The product is a latex agglutination slide test for the qualitative and semi quantitative in vitro determination of Rheumatoid Factor in serum.

The product is a latex agglutination slide test for the qualitative and semi quantitative in vitro determination of Rheumatoid Factor in serum.
RF - RF2716

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 a nephelometry/turbidimetry method.

Environmental Conditions

Special Storage Condition, Specify

The reagents must be allowed to reach room temperature before use. Do not freeze any of the reagents.

Storage Environment Temperature - Degrees Celsius

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 Identifiers

Device Id: 05055273205046

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