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...
A collection of devices and materials available for use by a patient/layperson outside a clinical setting to collect and, in some cases, mail a capillary blood sample to a clinical laboratory for diagnostic testing or screening purposes. The kit includes a ...
A collection of sterile devices and reagent solution intended to be used in vitro with an ultraviolet (UV) blood illuminator for photochemical treatment of donor blood (including whole blood, plasma, and/or platelet concentrates) to inactivate blood transfu...
A collection of sterile devices that is a component of a blood centrifugation system intended to be used during the centrifugation of blood, relative components or cellular products (e.g., umbilical cord blood, bone marrow), to automatically isolate constit...
A collection of 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 ...
A collection of 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 ...
A collection of sterile devices and materials intended to be used by a layperson 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 strip, dry blo...
A collection of devices intended to be used at the point-of-care to draw blood from a patient and produce an autologous whole blood clot tissue mass (gel-like) for temporary topical application to an exuding skin wound (e.g., diabetic or pressure ulcer, sur...
A collection of 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 ...
A collection of devices intended to be used by a healthcare professional at the point-of-care to collect a capillary blood sample from a patient for subsequent diagnostic testing or screening purposes. It typically includes a lancet and a blood collection d...
A collection of specifically characterized reagent red blood cells that are supplied together and intended to be used in reverse ABO blood group testing of a clinical specimen using an agglutination method. Cells are selected due to their individual blood g...
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...
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 include...
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 include...
A collection of sterile devices intended for use at the point-of-care for preparation of autologous thrombin (AT) from a blood specimen. The kit components, with the blood specimen, are directly placed in a dedicated centrifuge that separates the AT from th...
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...
A collection of sterile devices intended to obtain an arterial blood specimen directly from a patient, usually for the determination of blood gas concentration. It typically includes a needle, heparinized syringe, sterile gauze/swab, bandage, rubber band, s...
A collection of sterile devices designed to prepare platelet-rich plasma (PRP) or platelet-rich fibrin matrix (PRFM) from an autologous blood specimen for application to soft-tissue wounds and injured bone to accelerate healing and/or achieve haemostasis. I...
A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative determination of one or multiple whole blood cell parameters [also known as complete blood count (CBC)] in a clinical specimen using a manual...
A collection of four or more specifically characterized reagent red blood cells that are supplied together as a set and intended to be used to determine the exact specificity of antibodies to red blood cell antigens present in a clinical specimen, using an ...
A collection of two or three specifically characterized reagent red blood cells that are supplied together as a set and intended to be used when screening a clinical specimen to detect antibodies to red blood cell antigens, using an agglutination method.
A collection of reagents and other associated materials intended to be used to evaluate a clinical specimen to determine the genotype for one or multiple blood groups using a microarray technique. The blood group systems to be genotyped may include Rhesus (...
A collection of sterile devices and supplies used in combination for the implantation of an embolization implant that will purposely create permanent or temporary obstruction, i.e., stop the flow of blood, in arteries/blood vessels. The kit will typically c...
A collection of two or more bottles containing broth culture medium, with or without additional supplements and/or adsorbent compounds, intended to be used for the collection, preservation, and/or transport of a clinical blood specimen for culture, analysis...
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 ...
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...
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...
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...
A collection of reagents and other associated materials intended to be used for the quantitative measurement of multiple blood gas, haemoximetry and/or electrolyte analytes in a clinical sample, using multiple technologies such as ion-selective electrode (I...
A collection of devices designed to prepare platelet-rich plasma (PRP) or platelet-rich fibrin matrix (PRFM) from an autologous blood specimen for application to soft-tissue wounds and injured bone to accelerate healing and/or achieve haemostasis. It includ...