LetsGetChecked Blood Sample Collection Kit (LIPP2) BO19S

GUDID 00810111410045

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

Capillary blood collection kit IVD

• Primary Device ID: 00810111410045
• NIH Device Record Key: 1c3a6522-471c-4789-83a9-814eb9eedfc8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LetsGetChecked Blood Sample Collection Kit (LIPP2)
• Version Model Number: BO19S
• Catalog Number: BO19S
• 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	00810111410045 [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: 2025-07-15
• Device Publish Date: 2025-07-07

Devices Manufactured by PRIVAPATH DIAGNOSTICS LIMITED

• 00810111410045 - LetsGetChecked Blood Sample Collection Kit (LIPP2): 2025-07-15A 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
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• 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