RF LATEX Test Kit R-20

GUDID B224R201

Cenogenics Corporation's RF LATEX TEST KIT is a rapid latex slide test for the determination of Rheumatoid Factor in human serum. Kit Contains: 5 ml RF Latex Reagent 10 ml Glycine-Saline Buffer Concentrate 1 ml RF Positive Control 1 ml RF Negative Control 6-ring slide Product Instructions

CENOGENICS CORPORATION

Rheumatoid factor IVD, kit, agglutination

• Primary Device ID: B224R201
• NIH Device Record Key: 051f80f2-f7ab-49e1-99c6-c4d1bba0750a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RF LATEX Test Kit
• Version Model Number: R-20
• Catalog Number: R-20
• Company DUNS: 068288943
• Company Name: CENOGENICS CORPORATION
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Handling Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B224R201 [Primary]

FDA Product Code

• DHR: System, Test, Rheumatoid Factor

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-06-04
• Device Publish Date: 2021-05-27

Devices Manufactured by CENOGENICS CORPORATION

• B224R201 - RF LATEX Test Kit: 2021-06-04Cenogenics Corporation's RF LATEX TEST KIT is a rapid latex slide test for the determination of Rheumatoid Factor in human serum. Kit Contains: 5 ml RF Latex Reagent 10 ml Glycine-Saline Buffer Concentrate 1 ml RF Positive Control 1 ml RF Negative Control 6-ring slide Product Instructions
• B224R201 - RF LATEX Test Kit: 2021-06-04 Cenogenics Corporation's RF LATEX TEST KIT is a rapid latex slide test for the determination of Rheumatoid Factor in human serum
• B224SB191 - TRI-SLIDE PATIENT ENVELOPE KIT: 2021-06-04 Cenogenics Corporation's TRI-SLIDE PATIENT ENVELOPE KIT is a six test guaiac slide procedure to effectively screen for intermitt
• B224SB201 - TRI-SLIDE STOOL BLOOD TEST: 2021-06-04 Cenogenics Corporation's TRI-SLIDE STOOL BLOOD TEST is a six test guaiac slide procedure to effectively screen for intermittent
• B224SB211 - PROFESSIONAL SINGLE SLIDE KIT: 2021-06-04 Cenogenics Corporation's PROFESSIONAL SINGLE SLIDE KIT is a two test guaiac slide procedure to screen for gastrointestinal bleed
• B224V611 - VDRL CONTROL SERUM KIT: 2021-06-04 Cenogenics Corporation's VDRL CONTROL SERUM KIT is a set of syphilitic and non-syphilitic human sera for use with the VDRL slide
• B224V551 - VDRL Antigen Kit: 2018-03-29 VDRL Test Kit is intended for the qualitative and/or quantitative detection of non-specific reagin antibodies that are produced