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LetsGetChecked Blood and Urine Sample Collection Kit (ST05)

FDA UDI

by Privapath Diagnostics Limited

Identity

Trade Name
LetsGetChecked Blood and Urine Sample Collection Kit (ST05) FDA UDI
Generic Name
General specimen collection kit IVD, home-use FDA UDI
Device Name
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. FDA UDI
Model / Reference
BU04S FDA UDI
Description
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. FDA UDI

Identifiers

Catalog Number
BU04S FDA UDI
Primary DI / UDI-DI
00810111410311 FDA UDI
GMDN Term
General specimen collection kit IVD, home-use FDA UDI

Classification

Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

Yes

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: General specimen collection kit IVD, home-use

LetsGetChecked Blood and Urine Sample Collection Kit (ST05) by Privapath Diagnostics Limited — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as General specimen collection kit IVD, home-use.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Privapath Diagnostics Limited

Sources (1)

  • FDA UDI c6bba471-9ece-43b7-bbc6-54638f56b671 34 fields · synced May 29, 2026