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15 matching records for Home Health Kit.

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Urogenital specimen collection kit IVD, home-use

1 GUDID devices

A collection of devices intended to be used by a layperson in the home and healthcare professionals for the collection, and preservation and/or transport, of cellular and/or other material collected from the endocervix, vagina, and other male/female lower u...

Elastomeric infusion pump kit

681 GUDID devices

A collection of sterile devices designed to enable a healthcare provider or patient to perform infusion therapy using an elastomeric infusion pump. The kit typically consists of the infusion pump and other devices such as a catheter, tunneller, needle, shea...

Oral/upper respiratory tract specimen collection kit IVD, home-use

3 GUDID devices

A collection of devices intended to be used by a layperson in the home to self-collect and mail a saliva/oral, nasal, nasopharyngeal, and/or oropharyngeal specimen to a clinical laboratory for in vitro diagnostic investigation (e.g., COVID-19 testing); it m...

Compression bandaging kit

1,335 GUDID devices

A collection of various types of non-sterile bandages intended for use in the treatment of venous leg ulcers, and related conditions, by sequential bandage application to provide graduated ascending-decreasing compression from the ankle to the knee. Typical...

Compression bandaging kit

598 GUDID devices

A collection of various types of bandages intended for use in the treatment of venous leg ulcers, and related conditions, by sequential bandage application to provide graduated ascending-decreasing compression from the ankle to the knee. Typically the banda...

Podiatry kit, single-use

50 GUDID devices

A collection of devices intended for treatment of cutaneous foot disorders such as hardened skin, corns, and ingrown/ingrowing toenails. It typically consists of two or more of the following items: nail cutters, nail file, dermal curette, scalpel handle and...

Follicle stimulating hormone (FSH) IVD, kit, rapid ICT, self-testing

18 GUDID devices

A collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative detection of follicle stimulating hormone (FSH) in a clinical specimen within a short period, relative to standard laboratory testing ...

Rectal irrigation kit

17 GUDID devices

A collection of devices that includes a rectal irrigation nozzle (also known as a catheter) intended to be used as part of a rectal irrigation system for the introduction of a non-medicated solution (typically water) into the rectum for patients affected by...

Rectal irrigation kit

8 GUDID devices

A collection of non-sterile devices intended to be used as part of a rectal irrigation system for the introduction of a non-medicated solution (typically water) into the rectum for patients affected by faecal incontinence or constipation; it is not intended...

Carbon isotope breath test kit IVD

2 GUDID devices

A collection of devices intended to be used for the breath analysis of a carbon isotope (e.g., carbon-13, carbon-14) to investigate suspected gastrointestinal disorders [e.g., gastric emptying disorder (gastroparesis), H. pylori infection]. It consists of a...

Carbon-13 breath test kit IVD

2 GUDID devices

A collection of devices intended to be used for carbon-13 breath analysis to investigate suspected gastrointestinal disorders [e.g., gastric emptying disorder (gastroparesis), H. pylori infection]. It consists of an ingestible carbon-13 labelled substrate a...

Paediatric urine collection/analysis kit IVD

2 GUDID devices

A collection of devices intended to be used to collect and analyse a paediatric urine specimen for multiple clinical chemistry analytes (e.g., ketones, glucose and pH). It consists of a specimen collection undergarment (nappy or diaper) worn by the patient,...