A collection of devices intended exclusively for professional use to assist in the extraction/collection, and preservation and/or transport, of a saliva/oral, nasal, nasopharyngeal, and/or oropharyngeal specimen for in vitro diagnostic investigation. The ki...

Oral/upper respiratory tract specimen collection kit

58 GUDID devices

A collection of devices intended exclusively for professional use for the collection, and preservation and/or transport, of a saliva/oral, nasal, nasopharyngeal, and/or oropharyngeal specimen for subsequent laboratory analysis [e.g., nucleic acid technique ...

Urogenital specimen collection kit IVD, clinical

28 GUDID devices

A collection of devices intended exclusively for professional use for the collection, and preservation and/or transport, of cellular and/or other material collected from the endocervix, vagina, and other male/female lower urogenital area (e.g., urethra) for...

Urine specimen collection kit IVD

502 GUDID devices

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...

General specimen collection kit IVD, clinical

337 GUDID devices

A collection of in vitro diagnostic devices intended exclusively for professional use 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 di...

General specimen collection kit IVD, home-use

10 GUDID devices

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 re...

General specimen collection kit

505 GUDID devices

A collection of devices intended exclusively for professional use 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...

Rectal/faecal specimen collection kit

18 GUDID devices

A collection of devices intended exclusively for professional use for the collection, and preservation and/or transport, of a rectal/faecal specimen for subsequent laboratory analysis [e.g., nucleic acid technique (NAT), microbiological culture]. The kit co...

General specimen transport medium collection kit

2 GUDID devices

A collection of devices intended to be used for the collection, preservation, and transport of any type of clinical specimen (e.g., faeces, sputum, mucous, wound exudate, vaginal secretion) collected from any body part [e.g., natural orifice, skin (i.e., it...

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...

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...

Dried blood spot collection kit IVD

24 GUDID devices

A collection of devices and materials intended to be used by a healthcare professional at the point-of-care to collect a dried blood spot (DBS) specimen from capillary or venous blood, for subsequent diagnostic testing or screening. The kit typically includ...

Venous blood collection kit IVD

6 GUDID devices

A collection of in vitro diagnostic devices and materials intended for use by a healthcare professional at the point-of-care for the collection of a venous blood specimen, for subsequent diagnostic testing or screening. The kit typically includes venous acc...

Plasma filtration/collection kit IVD

16 GUDID devices

A collection of devices intended to be used for the separation through filtration and collection of plasma from a whole blood specimen for subsequent in vitro diagnostic investigation. It typically consists of a contained or encased selectively-permeable me...

General specimen transport medium collection kit, sterile

35 GUDID devices

A collection of sterile devices intended to be used for the collection, preservation, and transport of any type of clinical specimen (e.g., faeces, sputum, mucous, wound exudate, vaginal secretion) collected from any body part [e.g., natural orifice, skin (...

General specimen transport medium collection kit, non-sterile

17 GUDID devices

A collection of non-sterile devices intended to be used for the collection, preservation, and transport of any type of clinical specimen (e.g., faeces, sputum, mucous, wound exudate, vaginal secretion) collected from any body part [e.g., natural orifice, sk...

General specimen transport medium collection kit IVD

9 GUDID devices

A collection of in vitro diagnostic devices intended to be used for the collection, preservation, and transport of any type of clinical specimen (e.g., faeces, sputum, mucous, wound exudate, vaginal secretion) collected from any body part [e.g., natural ori...

General specimen collection kit IVD, transport medium

4 GUDID devices

General specimen collection kit IVD, no additive

3 GUDID devices

Oropharyngeal secretion specimen collection kit

2 GUDID devices

A collection of sterile devices intended for collection of a mucus/sputum specimen from the oropharynx of a neonate for microbiological examination; it might in addition be used to clear mucus from the oropharynx to assist respiration. It consists of a cath...

Faecal specimen collection kit IVD, home-use

71 GUDID devices

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. The kit ma...

Home faecal specimen collection kit

12 GUDID devices

A collection of non-sterile devices and materials intended to be used by a layperson to collect and mail a faecal (stool) sample to a clinical laboratory for diagnostic testing or screening purposes (e.g., occult blood, cytology). The kit includes a specime...

Home faecal specimen collection kit

6 GUDID devices

A collection of devices and materials intended to be used by a layperson in the home to self-collect and mail a faecal (stool) sample to a clinical laboratory for diagnostic testing or screening purposes (e.g., occult blood, cytology). The kit includes a sp...

Specimen mailer kit

25 GUDID devices

A collection of items intended to be used for the collection of a clinical specimen at home, and its subsequent transport to a remote clinical laboratory for diagnostic testing. The kit includes a specimen container, instructions for use, a test order form,...

Specimen mailer kit

14 GUDID devices

A collection of non-sterile items intended to be used for the collection of a clinical specimen at home, and its subsequent transport to a remote clinical laboratory for diagnostic testing. The kit includes a specimen container, instructions for use, a test...

Urogenital specimen transport medium collection kit

10 GUDID devices

A collection of sterile devices intended to be used for the collection, preservation, and transport of cellular and/or other material collected from the endocervix, vagina, and male/female urogenital area (e.g., urethra) for investigation by in vitro diagno...

Oral specimen collection kit, no additive

7 GUDID devices

A collection of non-sterile devices intended to be used for the collection, preservation, and transport of cellular and/or other material collected from the mouth, for investigation by in vitro diagnostic procedures [e.g., nucleic acid technique (NAT), micr...

Oral specimen collection kit, transport medium

5 GUDID devices

Oral specimen transport medium collection kit

3 GUDID devices

Saliva/oral specimen collection kit, no additive

1 GUDID devices

A collection of devices intended to be used for the collection, preservation, and transport of salivary, cellular, and/or other material collected from the mouth for laboratory analysis [e.g., by nucleic acid technique (NAT), microbiological culture]. It in...