Question 1

What types of medical devices does Accriva Diagnostics Holdings, Inc. manufacture?

Accepted Answer

Accriva Diagnostics Holdings, Inc. specializes in in vitro diagnostics (IVDs) focused on coagulation testing. Their product portfolio includes point-of-care and laboratory analysers designed to measure blood clotting factors, platelet aggregation, and oxygen saturation levels. They also produce reagents for tests like activated clotting time (ACT), multiple coagulation factors, and platelet function studies, as well as whole blood controls for coagulation assays. These devices are primarily used in both clinical and point-of-care settings to support blood management and patient care.

Question 2

Where is Accriva Diagnostics Holdings, Inc. based?

Accepted Answer

Accriva Diagnostics Holdings, Inc. is headquartered in the United States. The company’s location is relevant for understanding its regulatory framework, as it operates under U.S. regulatory standards, including those set by the FDA.

Question 3

Which regulatory registries or databases list Accriva Diagnostics Holdings, Inc.’s devices?

Accepted Answer

Accriva Diagnostics Holdings, Inc.’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry is used to track and identify medical devices authorized for use in the U.S., ensuring transparency and traceability for healthcare providers and regulators. The UDI system helps streamline device reporting and compliance efforts.

Question 4

How are Accriva Diagnostics Holdings, Inc.’s devices classified under FDA regulations?

Accepted Answer

Accriva Diagnostics Holdings, Inc.’s devices fall under two FDA classification categories: Class I and Class II. Class I devices generally pose minimal risk and are subject to general controls, while Class II devices involve a higher level of risk and may require additional performance standards or post-market surveillance. The classification depends on factors like the device’s intended use, potential risks, and the body system it interacts with, as outlined in FDA guidelines.

Question 5

What is the primary purpose of the coagulation analysers and reagents produced by Accriva Diagnostics Holdings, Inc.?

Accepted Answer

The coagulation analysers and reagents from Accriva Diagnostics Holdings, Inc. are designed to assess blood clotting function, which is critical for diagnosing and managing bleeding disorders, monitoring patients on anticoagulant therapy, and guiding surgical procedures. Point-of-care analysers, like those for activated clotting time (ACT), enable rapid testing in operating rooms or emergency settings, while laboratory analysers provide detailed coagulation profiles. Reagents ensure accurate and consistent test results, supporting clinical decision-making.

Device	Model / Reference	Registries	Class	Status
Avoximeter Whole Blood Oximeter	AVOX1000E	FDA UDI	Class II	Active
Hemochron Whole Blood Microcoagulation System	J103	FDA UDI	Class II	Active
GEM Hemochron 100 Low Range Activated Clotting Time Test (ACT-LR)	000GACT-LR	FDA UDI	Class II	Active
directCHECK Whole Blood Controls	DCJPT-A	FDA UDI	Class II	Active
Hemochron Whole Blood Coagulation System	PDAOK	FDA UDI	Class II	Active
VerifyNow System	86000D	FDA UDI	Class II	Active
Hemochron Whole Blood Microcoagulation System	J-1001	FDA UDI	Class II	Active
Hemochron Whole Blood Coagulation System	HRFTK-ACT	FDA UDI	Class II	Active
Hemochron Whole Blood Coagulation System	QCACT	FDA UDI	Class II	Active
Hemochron Whole Blood Microcoagulation System	ELITERF	FDA UDI	Class II	Active
Hemochron Whole Blood Coagulation System	HRDM3CD	FDA UDI	Class II	Active
directCHECK Whole Blood Controls	DCJCPT-A	FDA UDI	Class II	Active
directCHECK Whole Blood Controls	DCJCPT-N	FDA UDI	Class II	Active
Avoximeter Whole Blood CO-Oximeter	AVOX4000	FDA UDI	Class I	Active
Hemochron Whole Blood Coagulation System	HRS.110-L	FDA UDI	Class II	Active
directCHECK ACT+ Whole Blood Control, Level 2	000DCGACT-2	FDA UDI	Class II	Active
Hemochron Whole Blood Coagulation System	R-PRT400	FDA UDI	Class II	Active
Hemochron Whole Blood Coagulation System	HRFTCA510	FDA UDI	Class II	Active
Avoximeter Whole Blood Oximeter	AVOX1000EL	FDA UDI	Class II	Active
directCHECK Whole Blood Controls	DCJ-005	FDA UDI	Class II	Active
VerifyNow Platelet Reactivity Test	85225	FDA UDI	Class II	Active
Hemochron Whole Blood Microcoagulation System	J201	FDA UDI	Class II	Active
directCHECK Whole Blood Controls	DCJCAPTT-A	FDA UDI	Class II	Active
HepCheck Whole Blood Control	DCP214-N	FDA UDI	Class II	Active
directCHECK Whole Blood Controls	DCJACT-A	FDA UDI	Class II	Active
Hemochron Whole Blood Microcoagulation System	ELITEL	FDA UDI	Class II	Active
Avoximeter Whole Blood CO-Oximeter	4-QCYO	FDA UDI	Class I	Active
VerifyNow System	85047	FDA UDI	Class II	Active
directCHECK Whole Blood Controls	DCJLR-N	FDA UDI	Class II	Active
Hemochron Whole Blood Microcoagulation System	JACT+	FDA UDI	Class II	Active
VerifyNow Platelet Reactivity Test	85053	FDA UDI	Class II	Active
GEM Hemochron 100 Activated Clotting Time Plus Test (ACT+)	000GACT+	FDA UDI	Class II	Active
directCHECK Whole Blood Controls	DCJACT-N	FDA UDI	Class II	Active
Hemochron Whole Blood Coagulation System	R-PRT400K	FDA UDI	Class II	Active
VerifyNow System	86003	FDA UDI	Class II	Active
Hemochron Whole Blood Coagulation System	R-PRT200K	FDA UDI	Class II	Active
Avoximeter Whole Blood Oximeter	AVOX1000ERF	FDA UDI	Class II	Active
VerifyNow System	85063	FDA UDI	Class II	Active
HepCheck Whole Blood Control	DCP214-A	FDA UDI	Class II	Active
Hemochron Whole Blood Coagulation System	R-PRT200	FDA UDI	Class II	Active
Hemochron Whole Blood Microcoagulation System	JEA-QC	FDA UDI	Class II	Active
Hemochron Whole Blood Coagulation System	P214	FDA UDI	Class II	Active
Hemochron Whole Blood Coagulation System	HE-ESV	FDA UDI	Class II	Active
VerifyNow System	86003D	FDA UDI	Class II	Active
Tenderlett Finger Incision Device	TL100I	FDA UDI	Class II	Unknown
Hemochron Whole Blood Coagulation System	HRS.110-D	FDA UDI	Class II	Active
Hemochron Whole Blood Coagulation System	HR1003	FDA UDI	Class II	Active
Tenderlett Finger Incision Device	TL5000I	FDA UDI	Class II	Unknown
VerifyNow System	86003L	FDA UDI	Class II	Active
Hemochron Whole Blood Coagulation System	HRS.110	FDA UDI	Class II	Active

ACCRIVA DIAGNOSTICS HOLDINGS, INC.

What ACCRIVA DIAGNOSTICS HOLDINGS, INC. makes

Frequently asked questions

Information

Catalogue (83)

Related Companies

Authorised Representatives

Importers

Notified Bodies

Authorities