General specimen collection kit IVD, home-use

Definition
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.
GUDID devices
17
Last updated
2026-08-18 06:11:25

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00810111410199LetsGetChecked Blood and Saliva Sample Collection Kit (MHTPC)PRIVAPATH DIAGNOSTICS LIMITEDBS01S2026-08-07
00810111410533LetsGetChecked Blood and Urine Sample Collection Kit (ST04)PRIVAPATH DIAGNOSTICS LIMITEDBU09S2026-08-07
00810111410601LetsGetChecked Blood and Urine Sample Collection Kit (CKDRN2 & GLCSKED)PRIVAPATH DIAGNOSTICS LIMITEDBU08S2026-08-07
00810111410663LetsGetChecked Blood and Urine Sample Collection Kit (KDB1 & KDB2)PRIVAPATH DIAGNOSTICS LIMITEDBU11S2026-08-07
00810111410724LetsGetChecked Blood and Urine Sample Collection Kit (CM08B & CM08C)PRIVAPATH DIAGNOSTICS LIMITEDBU06S2026-08-07
00810111410809LetsGetChecked Blood and Urine Sample Collection Kit (ST05)PRIVAPATH DIAGNOSTICS LIMITEDBU04S2026-08-07
00810111410908LetsGetChecked Blood and Saliva Sample Collection Kit (PCOS3)PRIVAPATH DIAGNOSTICS LIMITEDBS02S2026-08-07
00850042963005Rhinostics, Inc.Rhinostics IncPG-1000012023-03-27
00850042963081Rhinostics, Inc.Rhinostics IncLV-2D1D0032023-03-27
00850042963104Rhinostics, Inc.Rhinostics IncLV-2D1D0022023-03-27
00850042963111Rhinostics, Inc.Rhinostics IncGW-UF1000012023-03-24
00810047421474N/AScientific Device Laboratory, Inc.2512023-02-01
00810047421481N/AScientific Device Laboratory, Inc.2522023-02-01
00810047421658N/AScientific Device Laboratory, Inc.252-9972023-02-01
00810047421665N/AScientific Device Laboratory, Inc.252-9992023-02-01
00810047421672N/AScientific Device Laboratory, Inc.252-CAP2023-02-01
00810111410311LetsGetChecked Blood and Urine Sample Collection Kit (ST05)PRIVAPATH DIAGNOSTICS LIMITEDBU04S2022-07-01