CURA

GUDID 06975141982086

The Xpeedy DOA20 is used for fluid pre-treatment and processing of samples in a toxicology lab setting, serving the purpose of sample dilution, subpackaging, incubation and sample transferring.

Cura Diagnostics Inc.

Pipetting system IVD

• Primary Device ID: 06975141982086
• NIH Device Record Key: 24b75ac2-0a25-4d69-8da6-b4ef1290497f
• Commercial Distribution Discontinuation: 2024-06-30
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CURA
• Version Model Number: Xpeedy DOA20
• Company DUNS: 119132639
• Company Name: Cura 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: false
• Serial Number: true
• Manufacturing Date: true
• 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	06975141982086 [Primary]

FDA Product Code

• JJH: Clinical Sample Concentrator

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: 2024-06-07
• Device Publish Date: 2024-05-30

Devices Manufactured by Cura Diagnostics Inc.

• 10860012318206 - Xpeedy: 2025-02-10 Xpeedy Vaccum Urine Collection Tube 13 mm x 100 mm, White Cap
• 10860012318213 - Xpeedy: 2025-02-10 Xpeedy Vaccum Urine Collection Tube 16 mm x 100 mm, Yellow Cap
• 10860012318220 - Xpeedy: 2025-02-10 Xpeedy Urine Collection Cup - 90mL, with Vaccum Lid, Sterile
• 00860012318230 - Xpeedy: 2024-07-29 The Xpeedy DOA20 Automated Sample Preparation for Triple Quadrupole LC/MS/MS Analysis is used for fluid pre-treatment and proces
• 06975141982086 - CURA: 2024-06-07The Xpeedy DOA20 is used for fluid pre-treatment and processing of samples in a toxicology lab setting, serving the purpose of sample dilution, subpackaging, incubation and sample transferring.
• 06975141982086 - CURA: 2024-06-07 The Xpeedy DOA20 is used for fluid pre-treatment and processing of samples in a toxicology lab setting, serving the purpose of s