LetsGetChecked Blood Sample Collection Kit (MHTB) BO112, BO903, BO12S

GUDID 00850024881310

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: 00850024881310
• NIH Device Record Key: a131bfe3-1f8b-4b7c-980e-a180c145d249
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LetsGetChecked Blood Sample Collection Kit (MHTB)
• Version Model Number: BO112, BO903, BO12S
• Catalog Number: BO112, BO903, BO12S
• 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	00850024881310 [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: 2022-04-13
• Device Publish Date: 2022-04-05

On-Brand Devices [LetsGetChecked Blood Sample Collection Kit (MHTB)]

• 00850024881310: A collection of in vitro diagnostic devices and materials available for use by a patient/laypers
• 00810111410175: A collection of in vitro diagnostic devices and materials available for use by a patient/laypers