LetsGetChecked Urine Sample Collection Kit (UACR/UACRL)

GUDID 00850024881846

A collection of noninvasive devices intended to be used for the collection, preservation, and transport of a urine specimen for culture, analysis, and/or other investigation. It typically consists of a primary urine collection receptacle (e.g., cup, conical tube, vessel), a urine preservation/transport tube [typically evacuated, with or without additives], and a transfer device for facilitating the aseptic transfer of a urine sample between receptacles; supportive devices for urine collection (e.g., wet wipes, absorbent pads, Foley catheter connector) and/or analysis [e.g., microscope slides, tube rack] may also be included in the kit. This is a single-use device.

PRIVAPATH DIAGNOSTICS LIMITED

Urine specimen collection kit IVD

• Primary Device ID: 00850024881846
• NIH Device Record Key: d8c7c292-b6bd-4cd3-be9c-3a6a2577d544
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LetsGetChecked Urine Sample Collection Kit (UACR/UACRL)
• Version Model Number: UO03S
• Company DUNS: 985578451
• Company Name: PRIVAPATH DIAGNOSTICS LIMITED
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• 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: false
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850024881846 [Primary]

FDA Product Code

• OIE: Urine Collection Kit (Excludes Hiv Testing)

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: 2025-07-15
• Device Publish Date: 2025-07-07

Devices Manufactured by PRIVAPATH DIAGNOSTICS LIMITED

• 00810111410045 - LetsGetChecked Blood Sample Collection Kit (LIPP2): 2025-07-15 A collection of in vitro diagnostic devices and materials available for use by a patient/layperson outside a clinical setting to
• 00810111410281 - LetsGetChecked Blood Sample Collection Kit (PRGS): 2025-07-15 A collection of in vitro diagnostic devices and materials available for use by a patient/layperson outside a clinical setting to
• 00810111410335 - LetsGetChecked Blood Sample Collection Kit (TSTS): 2025-07-15 A collection of in vitro diagnostic devices and materials available for use by a patient/layperson outside a clinical setting to
• 00810111410748 - LetsGetChecked Urine Sample Collection Kit (Penile): 2025-07-15 A collection of noninvasive devices intended to be used for the collection, preservation, and transport of a urine specimen for
• 00850024881846 - LetsGetChecked Urine Sample Collection Kit (UACR/UACRL): 2025-07-15A collection of noninvasive devices intended to be used for the collection, preservation, and transport of a urine specimen for culture, analysis, and/or other investigation. It typically consists of a primary urine collection receptacle (e.g., cup, conical tube, vessel), a urine preservation/transport tube [typically evacuated, with or without additives], and a transfer device for facilitating the aseptic transfer of a urine sample between receptacles; supportive devices for urine collection (e.g., wet wipes, absorbent pads, Foley catheter connector) and/or analysis [e.g., microscope slides, tube rack] may also be included in the kit. This is a single-use device.
• 00850024881846 - LetsGetChecked Urine Sample Collection Kit (UACR/UACRL): 2025-07-15 A collection of noninvasive devices intended to be used for the collection, preservation, and transport of a urine specimen for
• 00810111410212 - LetsGetChecked Blood Sample Collection Kit (MIC9): 2023-08-07 A collection of in vitro diagnostic devices and materials available for use by a patient/layperson outside a clinical setting to
• 00850024881976 - LetsGetChecked Blood Sample Collection Kit (GLCS): 2023-07-06 A collection of in vitro diagnostic devices and materials available for use by a patient/layperson outside a clinical setting to
• 00810111410090 - LetsGetChecked Blood Sample Collection Kit (HPTT): 2022-10-11 A collection of in vitro diagnostic devices and materials available for use by a patient/layperson outside a clinical setting to