LetsGetChecked Urine Sample Collection Kit (SM02) UO305, UO01S

GUDID 00850024881327

A collection of noninvasive devices intended to be used for the collection, and preservation and/or transport, of a urine specimen for culture, analysis, and/or other investigation.

PRIVAPATH DIAGNOSTICS LIMITED

Urine specimen collection kit IVD

• Primary Device ID: 00850024881327
• NIH Device Record Key: eae6cb6c-c7f5-44b3-806e-b99438abdd47
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LetsGetChecked Urine Sample Collection Kit (SM02)
• Version Model Number: UO305, UO01S
• Catalog Number: UO305, UO01S
• 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	00850024881327 [Primary]

FDA Product Code

• OIE: Urine Collection Kit (Excludes Hiv Testing)
• QYA: System For Detection Of Nucleic Acid From Non-Viral Microorganism(S) Causing Stis Using Specimens Collected At Home

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: 2022-04-07
• Device Publish Date: 2022-03-30

Devices Manufactured by PRIVAPATH DIAGNOSTICS LIMITED

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• 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
• 00810111410014 - LetsGetChecked Blood Sample Collection Kit (FMHM): 2022-10-10 A collection of in vitro diagnostic devices and materials available for use by a patient/layperson outside a clinical setting to
• 00810111410175 - LetsGetChecked Blood Sample Collection Kit (MHTB): 2022-10-10 A collection of in vitro diagnostic devices and materials available for use by a patient/layperson outside a clinical setting to
• 00810111410342 - LetsGetChecked Blood Sample Collection Kit (TRFN): 2022-10-10 A collection of in vitro diagnostic devices and materials available for use by a patient/layperson outside a clinical setting to
• 00810111410106 - LetsGetChecked Blood Sample Collection Kit (HPSP): 2022-07-11 A collection of in vitro diagnostic devices and materials available for use by a patient/layperson outside a clinical setting to
• 00810111410311 - LetsGetChecked Blood and Urine Sample Collection Kit (ST05): 2022-07-11 A collection of devices intended to be used by a layperson in the home for the collection, and preservation and/or transport, of