LetsGetChecked Stool Sample Collection Kit FT01S, FT102, FT101

GUDID 00850024881259

A collection of devices and materials intended to be used by a layperson in the home to self-collect a faecal (stool) sample for subsequent in vitro diagnostic testing or screening purposes (e.g., occult blood, cytology) in a clinical laboratory.

PRIVAPATH DIAGNOSTICS LIMITED

Faecal specimen collection kit IVD, home-use

• Primary Device ID: 00850024881259
• NIH Device Record Key: f9184137-15dd-4f48-b580-f7ac66f5f238
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LetsGetChecked Stool Sample Collection Kit
• Version Model Number: FT01S, FT102, FT101
• Catalog Number: FT01S, FT102, FT101
• 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	00850024881259 [Primary]

FDA Product Code

• NNK: Container, Specimen Mailer And Storage, Non-Sterile

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: 2022-05-12
• Device Publish Date: 2022-05-04

Devices Manufactured by PRIVAPATH DIAGNOSTICS LIMITED

• 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
• 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