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 ...

Oral/upper respiratory tract specimen collection kit IVD, clinical

10 GUDID devices

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 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...

Saliva pH IVD, kit, colorimetric dipstick, rapid

7 GUDID devices

A collection of reagents and other associated materials intended to be used for the qualitative and/or semi-quantitative screening of salivary pH within a short period, relative to standard laboratory testing procedures, using a colorimetric dipstick method...

Saliva pH IVD, kit, rapid colorimetric, clinical

4 GUDID devices

A collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative screening of salivary pH within a short period, relative to standard laboratory testing procedures, using a rapid colorimetric method....

Amylase isoenzyme IVD, kit, enzyme spectrophotometry

1 GUDID devices

A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of an amylase isoenzyme in a clinical specimen, using an enzyme spectrophotometry method. This test is typically used to detect sal...

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...

Drug-testing specimen collection kit IVD

47 GUDID devices

A covered receptacle and other associated materials/tools, available for use in the home and clinical settings, intended to be used for the collection, and preservation and/or transport, of a clinical specimen that may include hair, urine, sweat, or saliva ...

Drug-testing specimen collection kit IVD

43 GUDID devices

A covered receptacle and other associated materials/tools, available either [non-prescription] over-the-counter and/or to health professionals, intended to be used for the collection, and preservation and/or transport, of a clinical specimen that may includ...

Victim sexual-assault forensic evidence kit

1 GUDID devices

A collection of sterile devices and materials designed to be used during a forensic investigation to facilitate the acquisition of sexual-assault evidence from an alleged live victim. It typically includes devices to make and mail vaginal, rectal, and oral ...

Dental dry field kit

17 GUDID devices

A collection of devices and supplies used in orthodontic and restorative dentistry to maintain a dry oral cavity for treatment procedures. It provides the operator with easy access to the field of operation by holding the mouth open, displacing the tongue, ...

Free estriol (oestriol) IVD, kit, enzyme immunoassay (EIA)

8 GUDID devices

A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of free estriol (oestriol) in a clinical specimen, using an enzyme immunoassay (EIA) method. It is typically measured in maternal b...

Rubber dam kit

6 GUDID devices

A collection of devices used to apply and remove a rubber dam, which is created chairside and placed over the crown of a patient's tooth or teeth in order to eliminate saliva or to prevent the patient swallowing liquid/dental material during dental surgery....

NTRK gene mutation IVD, kit, nucleic acid technique (NAT)

1 GUDID devices

Collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of NTRK (e.g., NTRK1, NTRK2, and/or NTRK3) gene mutations and/or to evaluate a clinical specimen to predict or monitor the response t...