FDA.reportPublic FDA data

Tomcat®

Primary DI
15420045504677
Brand
Tomcat®
Company
Hologic, Inc.
Model
TOMCAT SYSTEM
Catalog number
ASY-07379
Device description
Tomcat® Instrument.
Published
2016-10-09
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

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
15420045504677PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1542004550467715420045504677

GMDN Terms#

Term, Definition table
TermDefinition
Laboratory container robotic transfer system IVD, automatedAn assembly of electrically-powered robotic devices, or stand-alone device, intended to be used for the automated transfer of assay containers (e.g., test tubes, microplates) between processing stations, as part of a pre-set algorithm or assay procedure. The system may interface with one or multiple individual instruments and/analysers, transferring assay containers between stations which may include specimen pipetting, reagent dispensing, incubation, microplate washing, agitation, barcode reading and/or optical reading. The device operates with minimal technician involvement and complete automation of all procedural steps.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature15 Degrees Celsius30 Degrees Celsius
Storage Environment Temperature5 Degrees Celsius45 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)442-9892CustomerSupport@hologic.com

Regulatory Flags#

DUNS number
050579217
Device count
1
DM exempt
true
Premarket exempt
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05420045503888SecurMarkSMARK-U-SS1SMARK-U-SS12015-09-04
05420045503895SecurMarkSMARK-U-SS2SMARK-U-SS22015-09-04
05420045503901SecurMarkSMARK-U-SS3SMARK-U-SS32015-09-04
15420045511859Unifi WorkspaceUnifi Workspace V1.02019-08-09
15420045515307Acessa ProVu System710071002023-05-16
15420045515314Acessa ProVu SystemMS-06-0171MS-06-01712023-05-16
15420045515284Acessa ProVu System520052002022-11-08
15420045513983BioZorbF0202F02022021-04-21
15420045513990BioZorbF0203F02032021-04-21
15420045514003BioZorbF0303F03032021-04-21
15420045514010BioZorbF0304F03042021-04-21
15420045514027BioZorbF0221F02212021-04-21
15420045514034BioZorbF0231F02312021-04-21
15420045514041BioZorbF0331F03312021-04-21
15420045514058BioZorbF0404F04042021-04-21
15420045514065BioZorbF0405F04052021-04-21
15420045512634Unifi WorkspaceUnifi Workspace V1.02020-09-21
15420045500020Selenia Dimensions C-View SoftwareC-ViewSW-030522014-09-05
15420045504561ATEC IntroducerAI090920AI0909202016-08-11
15420045504578ATEC IntroducerAI091220AI0912202016-08-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850054026392Diagnostic Automation, Inc.Diagnostic Automation, Inc.JQW2025-12-24
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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
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16975379910025QuaeroZhejiang Biorear Biotechnology Co., Ltd.JQW2025-05-14
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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
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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