LetsGetChecked Impress
Privapath Diagnostics Ltd (Dba Letsgetchecked)
Privapath Diagnostics Ltd
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3015209536 | 3015209536 | Privapath Diagnostics Ltd | 1 | N | 2026-01-01 | Unit 1, Northern Cross Business Park North Road Dublin 11 IE D11 XT26 |
| 3014267096 | 3014267096 | PrivaPath Diagnostics Inc | 1 | Y | 2020-04-25 | 58-19 58th Place Maspeth Maspeth NY US 11378 |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 227758 | 1570164691 | K242680 | LetsGetChecked Impress | FMK | 2025-01-13 |
| 227758 | 1105112550 | K212745 | ORAcollect®•Dx | OYJ | 2022-10-27 |
| 227758 | 1596872119 | K141410 | ORAGENE DX OGD-500.001 | OYJ | 2015-02-19 |
| 227758 | 1009923717 | DEN200070 | Simple 2 Test | QYA | 2023-11-15 |
| 215337 | 1041469549 | ||||
| 227758 | 1041469549 | ||||
| 227758 | 1557371849 | ||||
| 215337 | 1778835875 | ||||
| 227758 | 1778835875 | ||||
| 227758 | 1808650466 | ||||
| 215337 | 1808650466 | ||||
| 227758 | 1934686095 | ||||
| 215337 | 1934686095 | ||||
| 227758 | 1434457137 |
Product Codes Associated With Registrations#
PMN#
GUDID#
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.).
2025-07-07
LetsGetChecked Blood Sample Collection Kit (BIOM2) - 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
2026-05-06
Simple 2 Test (Simple 2 Swab Home Collection Kit (Vaginal) - 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 ofLetsGetChecked 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, PrivaPath laboratories (d.b.a. LetsGetChecked, Inc.).
2026-04-15
LetsGetChecked ImPress - The LetsGetChecked lmPress is a single-use blood lancing tool equipped with an integral sharps injury prevention feature. It is intended for use by health care professionals in producing capillary whole blood samples from the upper arm. To use the device, the user first removes the device tabs to expose the two internally contained lancets. The plastic strip liner is then removed, exposing a layer of medical adhesive. The device is then placed on the upper arm. Activation occurs when the device is compressedagainst the arm, causing two contact-activated lancets to puncture the skin. The lancets automatically retract to a safe position, preventing sharps injury and re-activation. The device operates solely through mechanical means. During activation, the device generates a vacuum against the skin, which facilitates the emergence of microliter quantities of capillary blood from the puncture site.
2026-04-15
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
2025-07-07
LetsGetChecked Blood Sample Collection Kit (PRGS) - 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
2025-07-07
LetsGetChecked Blood Sample Collection Kit (TSTS) - 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
2025-07-07
LetsGetChecked Urine Sample Collection Kit (UACR/UACRL) - A collection of noninvasive devices intended to be used for the collection, preservation, and transport of a urine specimen for culture, analysis, and/or other investigation. It typically consists of a primary urine collection receptacle (e.g., cup, conical tube, vessel), a urine preservation/transport tube [typically evacuated, with or without additives], and a transfer device for facilitating the aseptic transfer of a urine sample between receptacles; supportive devices for urine collection (e.g., wet wipes, absorbent pads, Foley catheter connector) and/or analysis [e.g., microscope slides, tube rack] may also be included in the kit. This is a single-use device.
2025-07-07
LetsGetChecked Urine Sample Collection Kit (SM02) - 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.
2022-03-30
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
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
2023-01-16
LetsGetChecked Blood Sample Collection Kit (FMHM) - 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.
2022-09-30
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.
2022-09-30
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
2022-09-30
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
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.
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.
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.
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.
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.
2022-04-01
LetsGetChecked Coronavirus (COVID-19) Home Sample Collection Test - 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.
2023-01-25
LetsGetChecked Blood and Urine Sample Collection Kit (ST05) - 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.
2022-07-01
LetsGetChecked Stool Sample Collection Kit - 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.
2022-05-04
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.
2022-03-30