GUDID 00860002740003

Incubating Kinetic Tube Reader for In Vitro Diagnostic (IVD) use, by professionals, in a clinical or laboratory setting.

LAB KINETICS LLC

Photometer, absorbance/transmission, manual Photometer, absorbance/transmission, manual Photometer, absorbance/transmission, manual Photometer, absorbance/transmission, manual Photometer, absorbance/transmission, manual Photometer, absorbance/transmission, manual Photometer, absorbance/transmission, manual Photometer, absorbance/transmission, manual Photometer, absorbance/transmission, manual Photometer, absorbance/transmission, manual Photometer, absorbance/transmission, manual Photometer, absorbance/transmission, manual Photometer, absorbance/transmission, manual Photometer, absorbance/transmission, manual Photometric/spectroscopic immunoassay analyser IVD Photometric/spectroscopic immunoassay analyser IVD Photometric/spectroscopic immunoassay analyser IVD Photometric/spectroscopic immunoassay analyser IVD Photometric/spectroscopic immunoassay analyser IVD Photometric/spectroscopic immunoassay analyser IVD Photometric/spectroscopic immunoassay analyser IVD Photometric/spectroscopic immunoassay analyser IVD Photometric/spectroscopic immunoassay analyser IVD Photometric/spectroscopic immunoassay analyser IVD Photometric/spectroscopic immunoassay analyser IVD Photometric/spectroscopic immunoassay analyser IVD Photometric/spectroscopic immunoassay analyser IVD Photometric/spectroscopic immunoassay analyser IVD Photometric/spectroscopic immunoassay analyser IVD Photometric/spectroscopic immunoassay analyser IVD Photometric/spectroscopic immunoassay analyser IVD Photometric/spectroscopic immunoassay analyser IVD Photometric/spectroscopic immunoassay analyser IVD Photometric/spectroscopic immunoassay analyser IVD Photometric/spectroscopic immunoassay analyser IVD Photometric/spectroscopic immunoassay analyser IVD Photometric/spectroscopic immunoassay analyser IVD Photometric/spectroscopic immunoassay analyser IVD Photometric/spectroscopic immunoassay analyser IVD Photometric/spectroscopic immunoassay analyser IVD Photometric/spectroscopic immunoassay analyser IVD Photometric/spectroscopic immunoassay analyser IVD Photometric/spectroscopic immunoassay analyser IVD Photometric/spectroscopic immunoassay analyser IVD Photometric/spectroscopic immunoassay analyser IVD Photometric/spectroscopic immunoassay analyser IVD Photometric/spectroscopic immunoassay analyser IVD

• Primary Device ID: 00860002740003
• NIH Device Record Key: ab91a55d-9e8c-44fa-ae99-9233fe078dd1
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: PKF08
• Company DUNS: 092773251
• Company Name: LAB KINETICS LLC
• 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: true
• 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	00860002740003 [Primary]

FDA Product Code

• JJQ: Colorimeter, Photometer, Spectrophotometer For Clinical Use

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2021-04-07
• Device Publish Date: 2020-11-06