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Accriva Diagnostics, Inc.

United States·US-MF-000009902

Last updated September 17, 2026

About

Through a dedicated focus on autoimmune in vitro diagnostics and lab automation, we anticipate the needs of the world's most advanced laboratories and clinics. Our highly accurate reagents and automated systems are designed to serve labs of all sizes, and they help improve the way patients with autoimmune diseases are diagnosed, monitored, and treated around the world.

From the manufacturer's own website. Source

Information

Country: United States
Address: 6260, Sequence Drive, San Diego, United States
Website: www.werfen.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: —
PRRC Contact: Paula Morgan
EUDAMED SRN: US-MF-000009902
FDA FEI Number: 2250033
DUNS Number: —

Catalogue (20)

Device	Model / Reference	Registries	Class	Status
Avoximeter	E-QCYO	EUDAMEDFDA UDI	IVD General	Active
GEM Hemochron 100 System, GEM Hemochron 100 Activated Clotting Time Plus Test (ACT+), GEM Hemochron 100 Low Range Activated Clotting Time Test (ACT-LR), directCHECK ACT+ Whole Blood Control, Level 1 and Level 2, directCHECK ACT-LR Whole Blood Control, Level 1 and Level 2	K202101	FDA 510(k)	Class II	Active
GEM® Hemochron™ 100 System	000GH100	EUDAMEDFDA UDI	Class A	Active
Avoximeter	C100B	EUDAMEDFDA UDI	IVD General	Active
Hemochron™ Signature Elite	ELITE	EUDAMEDFDA UDI	Class A	Active
VerifyNow™ System	86000	EUDAMEDFDA UDI	Class A	Active
Avoximeter	AVOX1000E-INT	EUDAMEDFDA UDI	IVD General	Active
Tenderfoot	TF1000I	EUDAMEDFDA UDI	Class IIa	Active
Hemochron™ Whole Blood Microcoagulation System	ELITEINT	EUDAMED	Class A	Active
Tenderfoot	TFP1000I	EUDAMEDFDA UDI	Class IIa	Active
GEM Hemochron 100	000GCCM	EUDAMEDFDA UDI	Class A	Active
VerifyNow	70068	EUDAMEDFDA UDI	Class A	Active
Tenderfoot	TFM50I	EUDAMEDFDA UDI	Class IIa	Active
Tenderfoot	TF200I	EUDAMEDFDA UDI	Class IIa	Active
Tenderfoot	TFT50I	EUDAMEDFDA UDI	Class IIa	Active
Tenderfoot	TF50I	EUDAMEDFDA UDI	Class IIa	Active
VerifyNow™ System	85062	EUDAMEDFDA UDI	Class A	Active
Tenderfoot	TFP200I	EUDAMEDFDA UDI	Class IIa	Active
Hemochron™	RPM-CD	EUDAMEDFDA UDI	Class A	Active
Tenderfoot Preemie	TFP50I	EUDAMEDFDA UDI	Class IIa	Active

Related Companies

Authorised Representatives

MDSS GmbH DE

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.

FDA Recalls (5)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Date	Recall No.	Class	Status	Reason
Nov 5, 2025	Z-0880-2026	—	open, classified	Test cuvettes, used with an assay for monitoring heparin anticoagulation, may have a foreign object that has sharp edges and could pose a risk of injury if not detected prior to handling.
Oct 21, 2025	Z-0500-2026	—	open, classified	Due to an device without a premarket clearance being incorrectly package and distributed.
Dec 2, 2024	Z-0961-2025	—	open, classified	Platelet Reactivity Test distributed without appropriate US-FDA market clearance; if used healthcare personnel could use the baseline PRUTest measurement prior to initiating drug therapy, and then use the percent inhibition formula in the notice to manually calculate the percentage of platelet aggregation inhibition for a given patient receiving drug treatment with P2Y12 receptor inhibitor.
Sep 27, 2024	Z-0279-2025	—	completed	Values used to calibrate whole blood oximeter instruments were observed to be higher than normal, which may result in incorrect patient results where oxygen levels are higher than actual results, which may lead to patient care mismanagement requiring medical intervention.
Mar 30, 2022	Z-1121-2022	—	terminated	Two whole blood Platelet Reactivity tests exist that share the same reagent formulation and are used to obtain P2Y12 Reactivity Unit results. The test without US-FDA market clearance was distributed and it displays BASE results not displayed by the US-FDA market cleared device. A formula is being provided to health care personnel to calculate the percentage of platelet aggregation inhibition.