PRIVAPATH DIAGNOSTICS LIMITED

GUDID#

LetsGetChecked Blood Sample Collection Kit (LIPP2) - The LetsGetChecked Blood Sample Collection Kit is an in vitro diagnostic medical device specifically intended for the primary containment and preservation of blood samples, for the purpose of in vitro diagnostic examination by our partner accredited laboratories.
PRIVAPATH DIAGNOSTICS LIMITED
2026-08-07
LetsGetChecked Blood Sample Collection Kit (HCV) - The LetsGetChecked Blood Sample Collection Kit is an in vitro diagnostic medical device specifically intended for the primary containment and preservation of blood samples, for the purpose of in vitro diagnostic examination by our partner accredited laboratories.
PRIVAPATH DIAGNOSTICS LIMITED
2026-08-07
LetsGetChecked Blood Sample Collection Kit (MHTP2) - The LetsGetChecked Blood Sample Collection Kit is an in vitro diagnostic medical device specifically intended for the primary containment and preservation of blood samples, for the purpose of in vitro diagnostic examination by our partner accredited laboratories.
PRIVAPATH DIAGNOSTICS LIMITED
2026-08-07
LetsGetChecked Blood and Saliva Sample Collection Kit (MHTPC) - The LetsGetChecked Blood and Saliva Sample Collection Kit is an in vitro diagnostic medical device specifically intended for the primary containment and preservation of blood and saliva samples, for the purpose of in vitro diagnostic examination by our partner accredited laboratories.
PRIVAPATH DIAGNOSTICS LIMITED
2026-08-07
LetsGetChecked Blood Sample Collection Kit (MHTP) - The LetsGetChecked Blood Sample Collection Kit is an in vitro diagnostic medical device specifically intended for the primary containment and preservation of blood samples, for the purpose of in vitro diagnostic examination by our partner accredited laboratories.
PRIVAPATH DIAGNOSTICS LIMITED
2026-08-07
LetsGetChecked Blood Sample Collection Kit (ANMH2) - The LetsGetChecked Blood Sample Collection Kit is an in vitro diagnostic medical device specifically intended for the primary containment and preservation of blood samples, for the purpose of in vitro diagnostic examination by our partner accredited laboratories.
PRIVAPATH DIAGNOSTICS LIMITED
2026-08-07
LetsGetChecked Blood Sample Collection Kit (TRFNUS+) - The LetsGetChecked Blood Sample Collection Kit is an in vitro diagnostic medical device specifically intended for the primary containment and preservation of blood samples, for the purpose of in vitro diagnostic examination by our partner accredited laboratories.
PRIVAPATH DIAGNOSTICS LIMITED
2026-08-07
LetsGetChecked Blood and Urine Sample Collection Kit (ST04) - The LetsGetChecked Blood and Urine Home Sample Collection Kit is an in vitro diagnostic medical device specifically intended for the primary containment and preservation of blood and urine samples, for the purpose of in vitro diagnostic examination by our partner accredited laboratories.
PRIVAPATH DIAGNOSTICS LIMITED
2026-08-07
LetsGetChecked Blood Sample Collection Kit (GLCS) - The LetsGetChecked Blood Sample Collection Kit is an in vitro diagnostic medical device specifically intended for the primary containment and preservation of blood samples, for the purpose of in vitro diagnostic examination by our partner accredited laboratories.
PRIVAPATH DIAGNOSTICS LIMITED
2026-08-07
LetsGetChecked Blood Sample Collection Kit (LEAD) - The LetsGetChecked Blood Sample Collection Kit is an in vitro diagnostic medical device specifically intended for the primary containment and preservation of blood samples, for the purpose of in vitro diagnostic examination by our partner accredited laboratories.
PRIVAPATH DIAGNOSTICS LIMITED
2026-08-07
LetsGetChecked Blood Sample Collection Kit (HPSP) - The LetsGetChecked Blood Sample Collection Kit is an in vitro diagnostic medical device specifically intended for the primary containment and preservation of blood samples, for the purpose of in vitro diagnostic examination by our partner accredited laboratories.
PRIVAPATH DIAGNOSTICS LIMITED
2026-08-07
LetsGetChecked Blood and Urine Sample Collection Kit (CKDRN2 & GLCSKED) - The LetsGetChecked Blood and Urine Home Sample Collection Kit is an in vitro diagnostic medical device specifically intended for the primary containment and preservation of blood and urine samples, for the purpose of in vitro diagnostic examination by our partner accredited laboratories.
PRIVAPATH DIAGNOSTICS LIMITED
2026-08-07
LetsGetChecked Blood Sample Collection Kit (OBIOMVA & OBIOMV) - The LetsGetChecked Blood Sample Collection Kit is an in vitro diagnostic medical device specifically intended for the primary containment and preservation of blood samples, for the purpose of in vitro diagnostic examination by our partner accredited laboratories.
PRIVAPATH DIAGNOSTICS LIMITED
2026-08-07
LetsGetChecked Blood and Urine Sample Collection Kit (KDB1 & KDB2) - The LetsGetChecked Blood and Urine Home Sample Collection Kit is an in vitro diagnostic medical device specifically intended for the primary containment and preservation of blood and urine samples, for the purpose of in vitro diagnostic examination by our partner accredited laboratories.
PRIVAPATH DIAGNOSTICS LIMITED
2026-08-07
LetsGetChecked Vaginal HPV Sample Collection Kit (HPVT & HPVT2) - The LetsGetChecked HPV Home Sample Collection Kit is an in vitro diagnostic medical device specifically intended for the primary containment and preservation of vaginal swab samples, for the purpose of in vitro diagnostic examination by our partner accredited laboratories.
PRIVAPATH DIAGNOSTICS LIMITED
2026-08-07
LetsGetChecked Blood Sample Collection Kit (EWB1) - The LetsGetChecked Blood Sample Collection Kit is an in vitro diagnostic medical device specifically intended for the primary containment and preservation of blood samples, for the purpose of in vitro diagnostic examination by our partner accredited laboratories.
PRIVAPATH DIAGNOSTICS LIMITED
2026-08-07
LetsGetChecked Blood Sample Collection Kit (EDB1) - The LetsGetChecked Blood Sample Collection Kit is an in vitro diagnostic medical device specifically intended for the primary containment and preservation of blood samples, for the purpose of in vitro diagnostic examination by our partner accredited laboratories.
PRIVAPATH DIAGNOSTICS LIMITED
2026-08-07
LetsGetChecked Blood and Urine Sample Collection Kit (CM08B & CM08C) - The LetsGetChecked Blood and Urine Home Sample Collection Kit is an in vitro diagnostic medical device specifically intended for the primary containment and preservation of blood and urine samples, for the purpose of in vitro diagnostic examination by our partner accredited laboratories.
PRIVAPATH DIAGNOSTICS LIMITED
2026-08-07
LetsGetChecked Blood Sample Collection Kit (KDRN) - The LetsGetChecked Blood Sample Collection Kit is an in vitro diagnostic medical device specifically intended for the primary containment and preservation of blood samples, for the purpose of in vitro diagnostic examination by our partner accredited laboratories.
PRIVAPATH DIAGNOSTICS LIMITED
2026-08-07
LetsGetChecked Blood and Urine Sample Collection Kit (ST05) - The LetsGetChecked Blood and Urine Home Sample Collection Kit is an in vitro diagnostic medical device specifically intended for the primary containment and preservation of blood and urine samples, for the purpose of in vitro diagnostic examination by our partner accredited laboratories.
PRIVAPATH DIAGNOSTICS LIMITED
2026-08-07
LetsGetChecked Blood Sample Collection Kit (CDST1) - The LetsGetChecked Blood Sample Collection Kit is an in vitro diagnostic medical device specifically intended for the primary containment and preservation of blood samples, for the purpose of in vitro diagnostic examination by our partner accredited laboratories.
PRIVAPATH DIAGNOSTICS LIMITED
2026-08-07
LetsGetChecked Stool Sample Collection Kit (FCIT) - A collection of devices and materials intended to be used by a layperson in the home to self-collect a faecal (stool) sample for subsequent in vitro diagnostic testing or screening purposes (e.g., occult blood, cytology) in a clinical laboratory.
PRIVAPATH DIAGNOSTICS LIMITED
2026-08-07
LetsGetChecked Blood and Saliva Sample Collection Kit (PCOS3) - The LetsGetChecked Blood and Saliva Sample Collection Kit is an in vitro diagnostic medical device specifically intended for the primary containment and preservation of blood and saliva samples, for the purpose of in vitro diagnostic examination by our partner accredited laboratories.
PRIVAPATH DIAGNOSTICS LIMITED
2026-08-07
LetsGetChecked Blood Sample Collection Kit (BIOM) - The LetsGetChecked Blood Sample Collection Kit is an in vitro diagnostic medical device specifically intended for the primary containment and preservation of blood samples, for the purpose of in vitro diagnostic examination by our partner accredited laboratories.
PRIVAPATH DIAGNOSTICS LIMITED
2026-08-07
LetsGetChecked Blood Sample Collection Kit (BIOM4) - The LetsGetChecked Blood Sample Collection Kit is an in vitro diagnostic medical device specifically intended for the primary containment and preservation of blood samples, for the purpose of in vitro diagnostic examination by our partner accredited laboratories.
PRIVAPATH DIAGNOSTICS LIMITED
2026-08-07
LetsGetChecked Blood Sample Collection Kit (GLCSLIPP2) - The LetsGetChecked Blood Sample Collection Kit is an in vitro diagnostic medical device specifically intended for the primary containment and preservation of blood samples, for the purpose of in vitro diagnostic examination by our partner accredited laboratories.
PRIVAPATH DIAGNOSTICS LIMITED
2026-08-07
LetsGetChecked Blood Sample Collection Kit (LIPP2) - 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
2025-07-07
LetsGetChecked Blood Sample Collection Kit (MIC9) - 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
2023-07-28
LetsGetChecked Blood Sample Collection Kit (GLCS) - 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
2023-01-16
LetsGetChecked Blood Sample Collection Kit (HPTT) - 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
2022-10-03
LetsGetChecked Blood Sample Collection Kit (HPSP) - 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
2022-07-01
LetsGetChecked Blood Sample Collection Kit (MHTB) - 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
2022-04-05
LetsGetChecked Blood Sample Collection Kit (TRFN) - 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
2022-04-05
LetsGetChecked Blood Sample Collection Kit (FOLT) - 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
2022-04-01
LetsGetChecked Blood Sample Collection Kit (TRFNUS+) - 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
2022-04-01
LetsGetChecked Urine Sample Collection Kit (BS03) - A collection of noninvasive devices intended to be used for the collection, and preservation and/or transport, of a urine specimen for culture, analysis, and/or other investigation.
PRIVAPATH DIAGNOSTICS LIMITED
2022-03-30
LetsGetChecked Coronavirus (COVID-19) Home Sample Collection Test (CRVSNH) - The LetsGetChecked Coronavirus (COVID-19) Home Collection Kit is a direct to consumer product for testing of anterior nasal swab specimens collected at home using the LetsGetChecked Coronavirus (COVID-19) Home Collection Kit by any individuals, age 18 years and older (self-collected), 12 years and older (self-collected under adult supervision), or 2 years and older (collected with adult assistance) including individuals without symptoms or other reasons to suspect COVID-19. The LetsGetChecked Coronavirus (COVID-19) Home Collection Kit enables the at-home collection of an anterior nasal swab sample that is then transported to a laboratory designated by LetsGetChecked, Inc. for TMA testing for SARS-CoV-2 with the LetsGetChecked Coronavirus (COVID-19) Test without prescription. The LetsGetChecked Coronavirus (COVID-19) Home Collection Kit may be available direct to consumer (DTC) without a prescription at a physical retail location and online direct to consumer. Activation can only be completed by an adult. When a minor is using the kit, it is activated in a sub-account of the adult. Customers cannot create a sub-account for an infant (<2years). LetsGetChecked HCP will contact all individuals receiving positive and invalid test results. Individuals with negative test results will be notified by email, phone message and through the website portal. For purposes of this EUA, a healthcare provider includes any healthcare professional with prescribing abilities including, but not limited to, physicians, nurses, pharmacists, and laboratory directors. The healthcare provider contacting individuals with test results will have prescribing privileges for that individual, should medication be indicated for treatment.
PRIVAPATH DIAGNOSTICS LIMITED
2023-01-25
LetsGetChecked Stool Sample Collection Kit (FCIT) - The LetsGetChecked Stool Home Sample Collection Kit is an in vitro diagnostic medical device specifically intended for the primary containment and preservation of stool samples, for the purpose of in vitro diagnostic examination by our partner accredited laboratories.
PRIVAPATH DIAGNOSTICS LIMITED
2022-05-04
LetsGetChecked Urine Sample Collection Kit (SM02) - The LetsGetChecked Urine Home Sample Collection Kit is an in vitro diagnostic medical device specifically intended for the primary containment and preservation of urine samples, for the purpose of in vitro diagnostic examination by our partner accredited laboratories.
PRIVAPATH DIAGNOSTICS LIMITED
2022-03-30
Simple 2 test (Simple 2 Urine Home Collection Kit (Penile)) - The Simple 2 Test is intended for in vitro detection and identification of Chlamydia trachomatis (CT) and/or Neisseria gonorrhoeae (GC) in home-collected specimens which are shipped to a clinical laboratory for testing using the Aptima Combo 2 Assay on the Panther System. This product is available over-the-counter (OTC) to consumers 18 years of age and older. The Simple 2 Test contains all the necessary components to collect urine from male patients (Simple 2 Urine Home Collection Kit (Penile)) or vaginal swabs from female patients (Simple 2 Swab Home Collection Kit (Vaginal)) in their home, or in similar environments, without supervision from a healthcare provider. The Simple 2 Test Collection Kits may also be used to self-collect specimens in a clinic. The testing is performed, as determined to be appropriate, based on the results of LetsGetChecked Suitability Questionnaire. This test system is not a substitute for visits to a healthcare provider. The information provided by this product should not be used to start, stop, or change any course of treatment unless advised by your healthcare provider. Testing is limited to the manufacturer, Priva Path laboratories (d.b.a. LetsGetChecked, Inc.).
PRIVAPATH DIAGNOSTICS LIMITED
2025-07-07

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