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40 matching records for ISolate®.

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Specimen transfer scooping tool IVD

101 GUDID devices

A hand-held manual instrument intended to be used to scoop a clinical specimen or microbial isolate for transfer from a primary vessel to a secondary container (e.g., from a specimen collection receptacle to a reagent tube, or from a culture medium to a gen...

Thermal cycler nucleic acid amplification analyser IVD, laboratory

46 GUDID devices

An electrically-powered automated or semi-automated laboratory instrument intended to amplify target deoxyribonucleic acid (DNA) or ribonucleic acid (RNA) in a clinical specimen using heat-stable polymerase enzymes and cycles of repeated heating and cooling...

Thermal cycler nucleic acid amplification analyser IVD, laboratory

35 GUDID devices

An electrically-powered automated or semi-automated laboratory instrument intended to amplify target deoxyribonucleic acid (DNA) or ribonucleic acid (RNA) in a clinical specimen using heat-stable polymerase enzymes and cycles of repeated heating and cooling...

Thermal cycler nucleic acid amplification analyser IVD, point-of-care

18 GUDID devices

A portable, electrically-powered instrument intended to be used by health professionals at the point-of-care to amplify target deoxyribonucleic acid (DNA) or ribonucleic acid (RNA) in a clinical specimen using heat-stable polymerase enzymes and cycles of re...

Patient surgical drape, single-use

5,710 GUDID devices

A noninvasive sheet designed to cover a portion of a patient’s anatomy during a surgical procedure to function as a barrier to cross contamination (e.g., isolate a site of surgical incision, protect non-operative anatomy). It is not designed with specific h...

Isolation gown, single-use

3,310 GUDID devices

A garment made of natural and/or synthetic materials intended to be worn by healthcare providers or visitors to isolate themselves from patients. The isolation gown helps to protect the patient (e.g., burn patients) from the transfer of infectious agents ca...

Endoscope sheath, reusable

2,717 GUDID devices

A component of a rigid or flexible endoscope assembly designed as a tube through which an endoscope (e.g., hysteroscope) and endoscopic elements are introduced and assembled to create a complete operative endoscopic unit; it is also designed to function as ...

Patient surgical drape, single-use, non-sterile

2,664 GUDID devices

A non-sterile, noninvasive flat sheet designed to cover a portion of a patient’s anatomy during a surgical procedure to isolate a specific anatomical site (e.g., site of surgical incision) from potential contamination (e.g., microbial, substance). The devic...

Patient surgical drape, single-use, sterile

1,869 GUDID devices

A sterile, noninvasive flat sheet designed to cover a portion of a patient’s anatomy during a surgical procedure to isolate a specific anatomical site (e.g., site of surgical incision) from potential contamination (e.g., microbial, substance). The device ma...

Patient surgical drape, single-use

1,437 GUDID devices

A noninvasive sheet designed to cover a portion of a patient’s anatomy during a surgical procedure to function as a barrier to cross contamination (e.g., isolate a site of surgical incision, protect non-operative anatomy). It is not designed with specific h...

Aneurysm clip

859 GUDID devices

A metallic device intended to be permanently implanted around the neck of an aneurysm (a balloon-like sac formed on a blood vessel) for occlusion, to prevent it from bleeding or bursting and to isolate it from the rest of the vessel. The device is typically...

Aneurysm clip, sterile

729 GUDID devices

A sterile, metallic device intended to be permanently implanted around the neck of an aneurysm (a balloon-like sac formed on a blood vessel) for occlusion, to prevent it from bleeding or bursting and to isolate it from the rest of the vessel. The device is ...

Incontinence pants, single-use

543 GUDID devices

An underwear designed to retain urine leakage in incontinent adults and older children. It typically consists of a single-use man?s brief or woman?s panty with external softness and shape resembling regular underwear, and an internal pad and/or isolated she...

Escherichia coli antigen IVD, antibody

471 GUDID devices

One or multiple immunoglobulins capable of binding to specific antigenic determinants and intended to be used for the qualitative and/or quantitative detection of antigens from Escherichia coli (E. coli) bacteria in a clinical specimen and/or culture isolate.

Rubber dam, Hevea-latex

453 GUDID devices

A sheet of elastomeric material made of Hevea natural rubber latex (NRL) that is punched with holes and placed over the teeth during dental procedures. It can have a variety of functions such as: 1) to isolate the field of operation from the rest of the ora...

Multiple Salmonella species culture isolate antigen IVD, reagent

442 GUDID devices

A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of antigens from one or multiple species of Salmonella bacteria isolated by cult...

Endoscope sheath, single-use

384 GUDID devices

A component of a rigid or flexible endoscope assembly designed as a tube through which an endoscope (e.g., hysteroscope) and endoscopic elements are introduced and assembled to create a complete operative endoscopic unit; it is also designed to function as ...

Aneurysm clip, non-sterile

347 GUDID devices

A non-sterile, metallic device intended to be permanently implanted around the neck of an aneurysm (a balloon-like sac formed on a blood vessel) for occlusion, to prevent it from bleeding or bursting and to isolate it from the rest of the vessel. The device...

Isolation gown, reusable

333 GUDID devices

A garment made of natural and/or synthetic materials intended to be worn by healthcare providers or visitors to isolate themselves from patients. The isolation gown helps to protect the patient (e.g., burn patients) from the transfer of infectious agents ca...

Escherichia coli antigen IVD, control

319 GUDID devices

A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of antigens from Escherichia coli (E. coli) bacteria in a clinical specimen and/or culture isolate.

Patient surgical drape, reusable

303 GUDID devices

A noninvasive sheet designed to cover a portion of a patient’s anatomy during a surgical procedure to function as a barrier to cross contamination (e.g., isolate a site of surgical incision, protect non-operative anatomy). It is not designed with specific h...

Antibacterial minimum inhibitory concentration (MIC) IVD

301 GUDID devices

A graduated test strip or collection of reagents containing a specified concentration gradient of a specific antibiotic (i.e., a drug intended for treatment and/or prevention of a bacterial infection, excluding mycobacterial infection) intended to be used t...

General-purpose surgical drape, reusable, sterile

301 GUDID devices

A sterile protective covering made of natural or synthetic materials, or both, designed to isolate a site of surgical incision or a surgical field from contamination (e.g., microbial, substance) in various clinical settings (e.g., in an operating room or ca...

Patient surgical drape, reusable

287 GUDID devices

A noninvasive flat sheet designed to cover a portion of a patient’s anatomy during a surgical procedure to isolate a specific anatomical site (e.g., site of surgical incision) from potential contamination (e.g., microbial, substance). The device may also be...

Streptococcus pneumoniae culture isolate antigen IVD, antibody

251 GUDID devices

One or multiple immunoglobulins capable of binding to specific antigenic determinants and intended to be used for the qualitative detection of antigens from Streptococcus pneumoniae bacteria isolated by culture from a clinical specimen.