FDA.report

TOMCAT SYSTEM

Primary DI
15420045504677
Brand
TOMCAT SYSTEM
Company
Hologic, Inc.
Model
TOMCAT SYSTEM
Catalog number
ASY-07379
Published
2016-10-09
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
JQWSTATION, PIPETTING AND DILUTING, FOR CLINICAL USE

Product Code Classifications

CodeDeviceSpecialtyClass
JQWStation, Pipetting And Diluting, For Clinical UseClinical Chemistry1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
15420045504677PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
1542004550467715420045504677

GMDN Terms

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

TypeLowHighCondition
Handling Environment Temperature15 Degrees Celsius30 Degrees Celsius
Storage Environment Temperature5 Degrees Celsius45 Degrees Celsius

Sterilization Methods

Method

Contacts

PhoneEmail
+1(800)442-9892CustomerSupport@hologic.com

Regulatory Flags

DUNS number
050579217
Device count
1
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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