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 Rheumatoid factor IVD, kit, agglutination Rheumatoid factor IVD, kit, agglutination Rheumatoid factor IVD, kit, agglutination Rheumatoid factor IVD, kit, agglutination Rheumatoid factor IVD, kit, agglutination Rheumatoid factor IVD, kit, agglutination Rheumatoid factor IVD, kit, agglutination Rheumatoid factor IVD, kit, agglutination Rheumatoid factor IVD, kit, agglutination Rheumatoid factor IVD, kit, agglutination Rheumatoid factor IVD, kit, agglutination Rheumatoid factor IVD, kit, agglutination Rheumatoid factor IVD, kit, agglutination Rheumatoid factor IVD, kit, agglutination 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