LetsGetChecked Blood Sample Collection Kit (FMHM) BO20S

GUDID 00810111410014

A collection of in vitro diagnostic devices and materials available for use by a patient/layperson outside a clinical setting to collect and mail a capillary blood sample to a clinical laboratory for diagnostic testing or screening purposes. The kit includes a lancet, a blood collection container(s), and a return packing/envelope for mailing to the laboratory. This is a single-use device.

PRIVAPATH DIAGNOSTICS LIMITED

Home blood collection kit IVD

• Primary Device ID: 00810111410014
• NIH Device Record Key: b79c8ddc-6ab5-4710-91ac-9ac070096211
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LetsGetChecked Blood Sample Collection Kit (FMHM)
• Version Model Number: BO20S
• Catalog Number: BO20S
• 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	00810111410014 [Primary]

FDA Product Code

• PQD: Blood Specimen Collection Convenience Kit (Excludes Hiv)

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: 2022-10-10
• Device Publish Date: 2022-09-30

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): 2022-10-10A collection of in vitro diagnostic devices and materials available for use by a patient/layperson outside a clinical setting to collect and mail a capillary blood sample to a clinical laboratory for diagnostic testing or screening purposes. The kit includes a lancet, a blood collection container(s), and a return packing/envelope for mailing to the laboratory. This is a single-use device.
• 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