FDA.reportPublic FDA data

Cologuard Capture Aspirator

Primary DI
00858637005895
Brand
Cologuard Capture Aspirator
Company
EXACT SCIENCES CORPORATION
Model
300490
Published
2022-12-08
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
JQWStation, Pipetting And Diluting, For Clinical Use

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JQWStation, Pipetting And Diluting, For Clinical UseClinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00858637005895PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00858637005895008586370058958586370058950858637005895

GMDN Terms#

Term, Definition table
TermDefinition
Pipetting system IVDAn electrically-powered, software-operated instrument intended to be used in the laboratory to withdraw, transfer, and/or inject volumes of fluid materials, typically from one laboratory container to another, during an in vitro diagnostic procedure. The device is programmable to allow for automated single and/or multichannel fluid handling and delivery of user-specified volumes into a single container or multiple containers (e.g., microplate) simultaneously. It has no other specimen processing capabilities.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
150908853
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850057859096Cologuard ® Collection Kit1009262026-04-22
00858637005840Analysis Server v2.22.22025-03-19
00858637005857Analysis Client v2.22.22025-03-19
00858637005864STARlet Interface v2.22.22025-03-19
00858637005871Cycler Control v2.22.22025-03-19
00858637005888Cologuard Test Definition v1.71.72025-03-19
00858637005901Cologuard 2 Test Definition1.12025-03-19
00858637005949The Cologuard Plus Collection Kit1006762025-03-19
00850057859003CG2 CAP BDS1006992025-02-19
00850057859010CG2 CAP WSH1005182025-02-19
00850057859027CG2 BND SLN1007002025-02-19
00850057859034CG2 REC BFR1005422025-02-19
00858637005918CG2 CNV WSH1005432025-02-19
00858637005925CG2 WSH1005882025-02-19
00858637005963DNA and LQAS Reagent SLIB Group Kit1007292025-02-19
00858637005970DNA Controls SLIB Group Kit1007282025-02-19
00858637005987Hemoglobin Bead Based Assay Reagents SLIB Group Kit1007272025-02-19
00858637005994Hemoglobin Bead Controls SLIB Goup Kit1007302025-02-19
00858637005345CAP SLN1002512024-11-20
00858637005833Reader Control v2.22.22024-04-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850054026392Diagnostic Automation, Inc.Diagnostic Automation, Inc.JQW2025-12-24
08059304340147dIFine P15VISIA LAB SRLJQW2025-06-27
00884999051522Alinity mpABBOTT MOLECULAR INC.JQW2025-05-28
00884999048973Alinity mpABBOTT MOLECULAR INC.JQW2025-05-28
00884999051508Alinity mpABBOTT MOLECULAR INC.JQW2025-05-28
00884999051515Alinity mpABBOTT MOLECULAR INC.JQW2025-05-28
00884999051720Alinity mpABBOTT MOLECULAR INC.JQW2025-05-28
06975379910028QuaeroZhejiang Biorear Biotechnology Co., Ltd.JQW2025-05-14
06975379910035QuaeroZhejiang Biorear Biotechnology Co., Ltd.JQW2025-05-14
06975379910509QuaeroZhejiang Biorear Biotechnology Co., Ltd.JQW2025-05-14
16975379910025QuaeroZhejiang Biorear Biotechnology Co., Ltd.JQW2025-05-14
16975379910032QuaeroZhejiang Biorear Biotechnology Co., Ltd.JQW2025-05-14
16975379910506QuaeroZhejiang Biorear Biotechnology Co., Ltd.JQW2025-05-14
06975379910011QuaeroZhejiang Biorear Biotechnology Co., Ltd.JQW2025-05-13
16975379910018QuaeroZhejiang Biorear Biotechnology Co., Ltd.JQW2025-05-13
06975379910004QuaeroZhejiang Biorear Biotechnology Co., Ltd.JQW2025-05-12
07640137480288Veya Dx 6Tecan Schweiz AGJQW2025-03-31
07640137480295Veya Dx 9Tecan Schweiz AGJQW2025-03-31
07613336180112AVENIO Edge SystemRoche Molecular Systems, Inc.JQW2025-03-25
00819704020388FINDERBaebies, Inc.JQW2025-01-31
00819704020395FINDERBaebies, Inc.JQW2025-01-31
07613336155790AcfS L and D Equipment Installation BundleRoche Molecular Systems, Inc.JQW2025-01-30
07613336172353AcfS Library RobotRoche Molecular Systems, Inc.JQW2025-01-30
07613336172360AcfS Detection RobotRoche Molecular Systems, Inc.JQW2025-01-30
04250289513531HELMED® Automated IFA ProcessorAesku.Diagnostics GmbH & Co. KGJQW2025-01-03
00812589020979FontusCaliper Life Sciences, Inc.JQW2024-07-02
00812589021051FontusCaliper Life Sciences, Inc.JQW2024-07-02
00812589021068FontusCaliper Life Sciences, Inc.JQW2024-07-02
00812589021075FontusCaliper Life Sciences, Inc.JQW2024-07-02
00812589021082FontusCaliper Life Sciences, Inc.JQW2024-07-02