PRIVAPATH DIAGNOSTICS LIMITED

Address:Unit 1, Northern Cross Business Park,Dublin 11,IE

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Blood Specimen Collection Convenience Kit (Excludes Hiv) (PQD) (6) Container, Specimen Mailer And Storage, Non-Sterile (NNK) (1)

Premarket Exempt

No Yes

Clear

LetsGetChecked Blood Sample Collection Kit (FMHM) - 00810111410014 Catalog Number : BO20S

Device Description : A collection of in vitro diagnostic devices and materials available for use by a

Device Class : 2

Duns Number: 985578451

Premarket Exempt : No

Product Code : PQD

Prescription Use : No

Device Count : 1

LetsGetChecked Blood Sample Collection Kit (HPTT) - 00810111410090 Catalog Number : BO18S

Device Description : A collection of in vitro diagnostic devices and materials available for use by a

Device Class : 2

Duns Number: 985578451

Premarket Exempt : No

Product Code : PQD

Prescription Use : No

Device Count : 1

LetsGetChecked Blood Sample Collection Kit (HPSP) - 00810111410106 Catalog Number : BO17S

Device Description : A collection of in vitro diagnostic devices and materials available for use by a

Device Class :

Duns Number: 985578451

Premarket Exempt : Yes

Product Code :

Prescription Use : No

Device Count : 1

LetsGetChecked Blood Sample Collection Kit (MHTB) - 00810111410175 Catalog Number : BO12S

Device Description : A collection of in vitro diagnostic devices and materials available for use by a

Device Class : 2

Duns Number: 985578451

Premarket Exempt : No

Product Code : PQD

Prescription Use : No

Device Count : 1

LetsGetChecked Blood and Urine Sample Collection Kit (ST05) - 00810111410311 Catalog Number : BU04S

Device Description : A collection of devices intended to be used by a layperson in the home for the c

Device Class :

Duns Number: 985578451

Premarket Exempt : Yes

Product Code :

Prescription Use : No

Device Count : 1

LetsGetChecked Blood Sample Collection Kit (TRFN) - 00810111410342 Catalog Number : BO07S

Device Description : A collection of in vitro diagnostic devices and materials available for use by a

Device Class : 2

Duns Number: 985578451

Premarket Exempt : No

Product Code : PQD

Prescription Use : No

Device Count : 1

LetsGetChecked Blood Sample Collection Kit (FOLT) - 00850024881020 Catalog Number : BO125

Device Description : A collection of in vitro diagnostic devices and materials available for use by a

Device Class : 2

Duns Number: 985578451

Premarket Exempt : No

Product Code : PQD

Prescription Use : No

Device Count : 1

LetsGetChecked Urine Sample Collection Kit (BS03) - 00850024881242 Catalog Number : UO301, UO02S

Device Description : A collection of noninvasive devices intended to be used for the collection, and

Device Class :

Duns Number: 985578451

Premarket Exempt : Yes

Product Code :

Prescription Use : No

Device Count : 1

LetsGetChecked Stool Sample Collection Kit - 00850024881259 Catalog Number : FT01S, FT102, FT101

Device Description : A collection of devices and materials intended to be used by a layperson in the

Device Class : 1

Duns Number: 985578451

Premarket Exempt : No

Product Code : NNK

Prescription Use : No

Device Count : 1

LetsGetChecked Blood Sample Collection Kit (MHTB) - 00850024881310 Catalog Number : BO112, BO903, BO12S

Device Description : A collection of in vitro diagnostic devices and materials available for use by a

Device Class : 2

Duns Number: 985578451

Premarket Exempt : No

Product Code : PQD

Prescription Use : No

Device Count : 1

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