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EXACT SCIENCES CORPORATION

United States·US-MF-000013637

Last updated May 23, 2026

What EXACT SCIENCES CORPORATION makes

Exact Sciences Corporation manufactures in vitro diagnostic products including nucleic acid extraction and isolation kits, faecal occult blood reagents, and laboratory instrument application software. Their portfolio also includes nucleic acid amplification mastermixes, exogenous DNA/RNA internal control kits, faecal specimen collection kits for home use, and automated pipetting systems.

The company is based in the United States and maintains a portfolio that spans Class I, Class III, and IVD General device classifications. These products are listed in the FDA PMA and UDI databases, as well as the EUDAMED registry.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Frequently asked questions

Where is Exact Sciences Corporation based and what do they manufacture?

Exact Sciences Corporation is based in the United States. They manufacture a variety of in vitro diagnostic products, including nucleic acid extraction and isolation kits, faecal occult blood reagents, and laboratory instrument application software. Their product range also encompasses nucleic acid amplification mastermixes, exogenous DNA/RNA internal control kits, faecal specimen collection kits for home use, and automated pipetting systems.

How are the devices from Exact Sciences Corporation classified?

The devices manufactured by Exact Sciences Corporation are categorized under multiple regulatory classifications. Their portfolio includes products designated as Class I, Class III, and IVD General devices. This classification reflects the diverse nature of their diagnostic offerings, ranging from collection kits to complex laboratory instrumentation and reagents.

Which regulatory registries list the devices produced by Exact Sciences Corporation?

The devices produced by Exact Sciences Corporation are documented in several major regulatory databases. You can find their products listed in the FDA PMA database, the FDA UDI database, and the EUDAMED registry. These listings provide transparency regarding the regulatory status and identification of their specific diagnostic products.

AI-generated from registry data and not verified by a human reviewer.

Information

Country: United States
Address: 5505, Endeavor Lane, Madison, United States
Website: exactsciences.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: —
PRRC Contact: Ingrid Mehlhorn
EUDAMED SRN: US-MF-000013637
FDA FEI Number: —
DUNS Number: 150908853

Catalogue (93)

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Device	Model / Reference	Registries	Class	Status
STP SLN Kit	100322	FDA UDI	Class III	Active
Cg2 Bnd Sln	100700	FDA UDI	Class III	Active
Cologuard Test Definition v1.4	1.4	FDA UDI	Class III	Unknown
ENZ Kit	100308	FDA UDI	Class III	Active
ELU BFR Kit	100312	FDA UDI	Class III	Active
Cologuard Hemoglobin Bead Based Assay Reagents Kit	100203	FDA UDI	Class III	Active
Cologuard Spin Filter	100105	FDA UDI	Class III	Unknown
Reader Control	2.0	FDA UDI	Class III	Unknown
CONJ Kit	100323	FDA UDI	Class III	Active
Cologuard FILT	100627	FDA UDI	Class III	Active
DIL BFR Kit	100326	FDA UDI	Class III	Active
Hemoglobin Bead Based Assay Reagents SLIB Group Kit	100727	FDA UDI	Class III	Active
Cologuard Stool Buffer	200204	FDA UDI	Class III	Active
Analytical Server	2.0	FDA UDI	Class III	Unknown
Cologuard Capture Bead Pre-Wash	100108	FDA UDI	Class III	Active
Cg2 Cnv Wsh	100543	FDA UDI	Class III	Active
STARlet Interface	2.0	FDA UDI	Class III	Unknown
Cologuard Hemoglobin Bead Based Control Kit	100204	FDA UDI	Class III	Active
CAP BDS Kit	100313	FDA UDI	Class III	Active
Cologuard Binding Solution	100106	FDA UDI	Class III	Active
STARlet Interface	2.1	FDA UDI	Class III	Active
Cg2 Rec Bfr	100542	FDA UDI	Class III	Active
HB CAP BEAD Kit	100321	FDA UDI	Class III	Active
Cologuard 2 Test Definition	1.1	FDA UDI	Class III	Active
Cap Sln	100251	FDA UDI	Class III	Active
Cologuard Barcoded Mixing Tubes	100110	FDA UDI	Class III	Unknown
D CAL 1 Kit	100304	FDA UDI	Class III	Active
DES SLN Kit	100314	FDA UDI	Class III	Active
Cologuard Hemoglobin Assay Reagents	100031	FDA UDI	Class III	Unknown
HB CTRL 2 Kit	100328	FDA UDI	Class III	Active
MIX B Kit	100310	FDA UDI	Class III	Active
The Cologuard Plus Collection Kit	100676	FDA UDI	Class III	Active
Reader Control v2.2	2.2	FDA UDI	Class III	Active
Analytical Server	2.1	FDA UDI	Class III	Active
Cycler Control	2.1	FDA UDI	Class III	Active
NEU SLN Kit	100315	FDA UDI	Class III	Active
DEN SLN Kit	100318	FDA UDI	Class III	Active
Cologuard Stool Buffer	200204	FDA UDI	Class III	Unknown
D CTRL 2 Kit	100301	FDA UDI	Class III	Active
Hemoglobin Bead Controls SLIB Goup Kit	100730	FDA UDI	Class III	Active
RESOLUTION ctDx FIRST	P210040	FDA PMA	Class III	Active
Cologuard Plus™	P230043	FDA PMA	Class III	Active
Cologuard	P130017	FDA PMA	Class III	Active

Related Companies

Authorised Representatives

No authorised representatives on record.

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.

FDA Recalls (1)

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

Exact Sciences Corporation has one recall record initiated on 2017-04-28, which is marked as terminated. The recall involved Sample Mixer v2 Upgrade units due to reported incidents of Sample Mixer door damage, described as occurring when the Sample Holder lid contacts the Sample Mixer door during operation.

AI-generated summary of the recall records listed below. It describes what the records state and is not an assessment of this manufacturer.

Date	Recall No.	Class	Status	Reason
Apr 28, 2017	Z-2219-2017	—	terminated	Exact Sciences is correcting all Sample Mixer v2 Upgrade units because of incidents of Sample Mixer door damage, which has occurred when the Sample Holder opens during a run and the Sample Holder lid makes contact with the Sample Mixer door.