LetsGetChecked Blood and Urine Sample Collection Kit (ST05) BU04S

GUDID 00810111410311

A collection of devices intended to be used by a layperson in the home for the collection, and preservation and/or transport, of more than one type of clinical specimen (e.g., urine, faeces, sputum, mucous, vaginal secretions) derived from different body regions for in vitro diagnostic investigation [e.g., nucleic acid technique (NAT), histopathology]. The kit consists of a specimen sampling/collection tool(s) [e.g., swab, brush, spatula, cup], and a covered specimen receptacle(s) with or without an additive/medium (e.g., preservation solution, microbiological medium) and mailing packing/envelope. It may include other relevant devices (e.g., a lancet). This is a single-use device.

PRIVAPATH DIAGNOSTICS LIMITED

General specimen collection kit IVD, home-use

• Primary Device ID: 00810111410311
• NIH Device Record Key: c6bba471-9ece-43b7-bbc6-54638f56b671
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LetsGetChecked Blood and Urine Sample Collection Kit (ST05)
• Version Model Number: BU04S
• Catalog Number: BU04S
• Company DUNS: 985578451
• Company Name: PRIVAPATH DIAGNOSTICS LIMITED
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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	00810111410311 [Primary]

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: 2022-07-11
• Device Publish Date: 2022-07-01

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): 2022-07-11A collection of devices intended to be used by a layperson in the home for the collection, and preservation and/or transport, of more than one type of clinical specimen (e.g., urine, faeces, sputum, mucous, vaginal secretions) derived from different body regions for in vitro diagnostic investigation [e.g., nucleic acid technique (NAT), histopathology]. The kit consists of a specimen sampling/collection tool(s) [e.g., swab, brush, spatula, cup], and a covered specimen receptacle(s) with or without an additive/medium (e.g., preservation solution, microbiological medium) and mailing packing/envelope. It may include other relevant devices (e.g., a lancet). This is a single-use device.
• 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