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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
LBgard Blood Tubes	100372	EUDAMED	IVD General	Active
DNA Controls SLIB Group Kit	100728	FDA UDI	Class III	Active
Cologuard Collection Kit	100026	FDA UDI	Class III	Active
Cologuard Conversion Wash	100107	FDA UDI	Class III	Active
PRE WSH Kit	100319	FDA UDI	Class III	Active
BND BDS Kit	100317	FDA UDI	Class III	Active
Cologuard Test Definition v1.7	1.7	FDA UDI	Class III	Active
Cologuard Hemoglobin Assay Wash	100111	FDA UDI	Class III	Unknown
Cologuard Capture Solution	100103	FDA UDI	Class III	Active
HB CTRL 3 Kit	100329	FDA UDI	Class III	Active
Analytical Client	2.0	FDA UDI	Class III	Unknown
Cologuard Spin Filter Kit	100283	FDA UDI	Class III	Unknown
Analytical Client	2.1	FDA UDI	Class III	Active
D CTRL 1 Kit	100300	FDA UDI	Class III	Active
D CAL 2 Kit	100305	FDA UDI	Class III	Active
Cg2 Cap Bds	100699	FDA UDI	Class III	Active
STARlet Interface v2.2	2.2	FDA UDI	Class III	Active
BIS SLN Kit	100316	FDA UDI	Class III	Active
Cologuard DNA Control Kit	100074	FDA UDI	Class III	Active
Cologuard DNA Preparation Reagent	100029	FDA UDI	Class III	Active
Cologuard Test Definition v1.3	1.3	FDA UDI	Class III	Unknown
D CTRL 3 Kit	100303	FDA UDI	Class III	Active
HB CTRL 1 Kit	100327	FDA UDI	Class III	Active
Cologuard Hemoglobin Bead Based Dilution Buffer Kit	100206	FDA UDI	Class III	Active
Cologuard Binding Solution Kit	100284	FDA UDI	Class III	Active
Cologuard Hemoglobin Control Kit	100073	FDA UDI	Class III	Unknown
Cologuard STL BFR	200631	FDA UDI	Class III	Active
SUBS Kit	100324	FDA UDI	Class III	Active
Cg2 Wsh	100588	FDA UDI	Class III	Active
Cologuard Capture Wash Kit	100282	FDA UDI	Class III	Active
CNV WSH Kit	100320	FDA UDI	Class III	Active
MIX A Kit	100309	FDA UDI	Class III	Active
Cologuard Capture Wash	100104	FDA UDI	Class III	Active
Analysis Client v2.2	2.2	FDA UDI	Class III	Active
Cologuard Capture Aspirator	300490	FDA UDI	Class I	Active
Cologuard Inhibitor Removal Tablet	100109	FDA UDI	Class III	Active
HB CAL Kit	100325	FDA UDI	Class III	Active
D CAL 4 Kit	100307	FDA UDI	Class III	Active
CAR SLN Kit	100311	FDA UDI	Class III	Active
Analysis Server v2.2	2.2	FDA UDI	Class III	Active
Cg2 Cap Wsh	100518	FDA UDI	Class III	Active
Home Page	2.0	FDA UDI	Class III	Active
Cologuard QuARTS Assay Reagents	100030	FDA UDI	Class III	Active
Cologuard DNA Capture Reagents	100028	FDA UDI	Class III	Active
Cologuard Hemoglobin Bead Based Assay Wash	100205	FDA UDI	Class III	Active
Cycler Control v2.2	2.2	FDA UDI	Class III	Active
Cologuard Inhibitor Removal Tablet Kit	100285	FDA UDI	Class III	Active
DNA and LQAS Reagent SLIB Group Kit	100729	FDA UDI	Class III	Active
Cologuard Test Definition v1.6	1.6	FDA UDI	Class III	Unknown
D CAL 3 Kit	100306	FDA UDI	Class III	Active

Related Companies

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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.