Address:Unit 1, Northern Cross Business Park,Dublin 11,IE
Device Description : A collection of in vitro diagnostic devices and materials available for use by a 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.
Device Class : 2
Duns Number: 985578451
Premarket Exempt : No
Prescription Use : No
Device Description : A collection of in vitro diagnostic devices and materials available for use by a 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
Device Class : 2
Duns Number: 985578451
Premarket Exempt : No
Prescription Use : No
Device Description : A collection of in vitro diagnostic devices and materials available for use by a 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.
Device Class :
Duns Number: 985578451
Premarket Exempt : Yes
Prescription Use : No
Device Description : A collection of in vitro diagnostic devices and materials available for use by a 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.
Device Class : 2
Duns Number: 985578451
Premarket Exempt : No
Prescription Use : No
Device Description : A collection of devices intended to be used by a layperson in the home for the c 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.
Device Class :
Duns Number: 985578451
Premarket Exempt : Yes
Prescription Use : No
Device Description : A collection of in vitro diagnostic devices and materials available for use by a 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
Device Class : 2
Duns Number: 985578451
Premarket Exempt : No
Prescription Use : No
Device Description : A collection of in vitro diagnostic devices and materials available for use by a 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.
Device Class : 2
Duns Number: 985578451
Premarket Exempt : No
Prescription Use : No
Device Description : A collection of noninvasive devices intended to be used for the collection, and 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.
Device Class :
Duns Number: 985578451
Premarket Exempt : Yes
Prescription Use : No
Device Description : A collection of devices and materials intended to be used by a layperson in the 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.
Device Class : 1
Duns Number: 985578451
Premarket Exempt : No
Prescription Use : No
Device Description : A collection of in vitro diagnostic devices and materials available for use by a 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.
Device Class : 2
Duns Number: 985578451
Premarket Exempt : No
Prescription Use : No