Carolina Liquid Chemistries Corp. Immunofluorescence Analyzer RYAN

GUDID 00817302022339

CAROLINA LIQUID CHEMISTRIES CORPORATION

Fluorescent immunoassay analyser IVD, laboratory Fluorescent immunoassay analyser IVD, laboratory Fluorescent immunoassay analyser IVD, laboratory Fluorescent immunoassay analyser IVD, laboratory Fluorescent immunoassay analyser IVD, laboratory Fluorescent immunoassay analyser IVD, laboratory Fluorescent immunoassay analyser IVD, laboratory Fluorescent immunoassay analyser IVD, laboratory Fluorescent immunoassay analyser IVD, laboratory Fluorescent immunoassay analyser IVD, laboratory Fluorescent immunoassay analyser IVD, laboratory Fluorescent immunoassay analyser IVD, laboratory Fluorescent immunoassay analyser IVD, laboratory Fluorescent immunoassay analyser IVD, laboratory Fluorescent immunoassay analyser IVD, laboratory Fluorescent immunoassay analyser IVD, laboratory Fluorescent immunoassay analyser IVD, laboratory

• Primary Device ID: 00817302022339
• NIH Device Record Key: 2b30103e-674b-48f7-af8d-969fd2a14e8a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Carolina Liquid Chemistries Corp. Immunofluorescence Analyzer RYAN
• Version Model Number: CLCE1106
• Company DUNS: 962385787
• Company Name: CAROLINA LIQUID CHEMISTRIES 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: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00817302022339 [Primary]

FDA Product Code

• KHO: FLUOROMETER, FOR CLINICAL USE

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: 2023-03-20
• Device Publish Date: 2023-03-10

Devices Manufactured by CAROLINA LIQUID CHEMISTRIES CORPORATION

• 00817302022353 - Carolina Liquid Chemistries Corp. Basic Multi-Drug Control Set: 2023-04-04
• 00817302022339 - Carolina Liquid Chemistries Corp. Immunofluorescence Analyzer RYAN: 2023-03-20
• 00817302022339 - Carolina Liquid Chemistries Corp. Immunofluorescence Analyzer RYAN: 2023-03-20
• 00817302022346 - Carolina Liquid Chemistries Corp. Fentanyl Detection Kit: 2023-03-20
• 00817302024678 - CAROLINA LIQUID CHEMISTRIES CORP.® OXIDANT REAGENT CC445: 2022-12-12 Oxidant Reagent (CC445)
• 00817302024654 - Caldon Biotech Aldolase Reagent: 2022-12-08 Aldolase
• 00817302024661 - Caldon Biotech Serum Aldolase Controls: 2022-12-08 Aldolase Controls
• 00817302024647 - CAROLINA LIQUID CHEMISTRIES CORP.® ALKALINE AMINOTRANSFERASE REAGENT AU-240: 2022-10-26 Alkaline Aminotransferase (ALT) (GPT) Reagent
• 00817302024104 - CAROLINA LIQUID CHEMISTRIES CORP.® MAGNESIUM REAGENT KIT AU-220: 2022-08-29 Magnesium Arsenazo Reagent (MG)