LetsGetChecked Blood and Urine Sample Collection Kit (ST05)

Primary DI
00810111410311
Brand
LetsGetChecked Blood and Urine Sample Collection Kit (ST05)
Company
PRIVAPATH DIAGNOSTICS LIMITED
Model
BU04S
Catalog number
BU04S
Device 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.
Published
2022-07-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810111410311PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810111410311008101114103118101114103110810111410311

GMDN Terms#

Term, Definition table
TermDefinition
General specimen collection kit IVD, home-useA 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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
985578451
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810111410038LetsGetChecked Blood Sample Collection Kit (LIPP2)BO19SBO19S2026-08-07
00810111410052LetsGetChecked Blood Sample Collection Kit (HCV)BO36SBO36S2026-08-07
00810111410182LetsGetChecked Blood Sample Collection Kit (MHTP2)BO28SBO28S2026-08-07
00810111410199LetsGetChecked Blood and Saliva Sample Collection Kit (MHTPC)BS01SBS01S2026-08-07
00810111410205LetsGetChecked Blood Sample Collection Kit (MHTP)BO27SBO27S2026-08-07
00810111410250LetsGetChecked Blood Sample Collection Kit (ANMH2)BO11SBO11S2026-08-07
00810111410366LetsGetChecked Blood Sample Collection Kit (TRFNUS+)BO06SBO06S2026-08-07
00810111410533LetsGetChecked Blood and Urine Sample Collection Kit (ST04)BU09SBU09S2026-08-07
00810111410540LetsGetChecked Blood Sample Collection Kit (GLCS)BO47SBO47S2026-08-07
00810111410557LetsGetChecked Blood Sample Collection Kit (LEAD)BO39SBO39S2026-08-07
00810111410588LetsGetChecked Blood Sample Collection Kit (HPSP)BO17SBO17S2026-08-07
00810111410601LetsGetChecked Blood and Urine Sample Collection Kit (CKDRN2 & GLCSKED)BU08SBU08S2026-08-07
00810111410649LetsGetChecked Blood Sample Collection Kit (OBIOMVA & OBIOMV)BO48SBO48S2026-08-07
00810111410663LetsGetChecked Blood and Urine Sample Collection Kit (KDB1 & KDB2)BU11SBU11S2026-08-07
00810111410670LetsGetChecked Vaginal HPV Sample Collection Kit (HPVT & HPVT2)VS01SVS01S2026-08-07
00810111410694LetsGetChecked Blood Sample Collection Kit (EWB1)BO50SBO50S2026-08-07
00810111410700LetsGetChecked Blood Sample Collection Kit (EDB1)BO51SBO51S2026-08-07
00810111410724LetsGetChecked Blood and Urine Sample Collection Kit (CM08B & CM08C)BU06SBU06S2026-08-07
00810111410793LetsGetChecked Blood Sample Collection Kit (KDRN)BO14SBO14S2026-08-07
00810111410809LetsGetChecked Blood and Urine Sample Collection Kit (ST05)BU04SBU04S2026-08-07