TrueSpin

GUDID 00860001286564

TrueSpin

MEDTOX DIAGNOSTICS, INC.

General-purpose centrifuge IVD

• Primary Device ID: 00860001286564
• NIH Device Record Key: 95b88c03-10c7-44f1-991c-00fa66afc687
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TrueSpin
• Version Model Number: S001
• Company DUNS: 118569262
• Company Name: MEDTOX DIAGNOSTICS, INC.
• 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: true
• 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: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860001286564 [Primary]

FDA Product Code

• JQC: Centrifuges (Micro, Ultra, Refrigerated) 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: 2024-12-23
• Device Publish Date: 2024-12-13

Devices Manufactured by MEDTOX DIAGNOSTICS, INC.

• 00860001286564 - TrueSpin: 2024-12-23TrueSpin
• 00860001286564 - TrueSpin: 2024-12-23 TrueSpin
• 10690286000756 - PROFILE®-V MEDTOXScan®: 2023-08-09 A qualitative one-step immunochromatographic test panel for the detection of THC (Cannabinoids), Phencyclidine, Cocaine, Methamp
• 10690286000763 - PROFILE®-V MEDTOXScan®: 2023-08-09 A qualitative one-step immunochromatographic test panel for the detection of THC (Cannabinoids), Phencyclidine, Cocaine, Methamp
• 10690286000770 - PROFILE®-IIA: 2023-06-09 A qualitative one-step immunochromatographic test panel for the detection of Cannabinoids (THC), Opiates, Amphetamine, Cocaine,
• 00690286000780 - PROFILE-II ER®: 2023-06-09 A qualitative one-step immunochromatographic test panel for the detection of Cannabinoids (THC), Opiates, Amphetamines, Cocaine,
• 00860001286533 - Men's Rapid Fertility Test: 2022-08-03 Men's Rapid Fertility Test, QC Kit
• 00862105000398 - Trak: 2022-07-13 Trak Male Fertility Testing System, 1-Test Kit
• 00862105000305 - Men's Rapid Fertility Test: 2022-06-21 Men's Rapid Fertility Test, 2-Test Kit