FDA.reportPublic FDA data

Sysmex HST Interface, TCA

Primary DI
06438153000471
Brand
Sysmex HST Interface, TCA
Company
Thermo Fisher Scientific Oy
Model
1
Catalog number
952054
Device description
Sysmex HST Interface, TCA is a module of TCAutomation Laboratory Automation System. TCAutomation is a modular system used to automate the handling of sample tubes in the pre- and post- analytical steps of in vitro examination procedures, typically in combination with in vitro diagnostic medical devices.
Published
2023-07-25
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
LXGEquipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LXGEquipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical UseClinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06438153000471PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06438153000471064381530004716438153000471

GMDN Terms#

Term, Definition table
TermDefinition
Specimen processing instrument IVDAn electrically-powered instrument or platform intended to be used for the automated or semi-automated pre-analytical preparation of a clinical specimen (excluding specimens for microbial culture), which may include the sampling, diluting, and/or aliquoting of clinical specimens and/or any post-analytical processing required, including labelling, storage and/or location data.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
540096708
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06438153000129Entry, TCA19520152023-07-26
06438153000143Exit, TCA19520162023-07-26
06438153000211Conveyor 600, TCA19520212023-07-26
06438153000228Conveyor 1200, TCA19520222023-07-26
06438153000235Conveyor 1500, TCA19520232023-07-26
06438153000259Conveyor 2400, TCA19520252023-07-26
06438153000266L-Turn, TCA19520272023-07-26
06438153000297Conveyor 900, TCA19520302023-07-26
06438153000303Conveyor 2100, TCA19520312023-07-26
06438153520139Buffer, TCA19520132023-07-26
06438153000099Interface, TCA ARCHITECT i2000SR19522342023-07-25
06438153000242Conveyor 1800, TCA19520242023-07-25
06438153000327Decapper Flex, TCA19520392023-07-25
06438153000358Perpendicular Bypass, TCA Vitros 5.1 FS AT19520432023-07-25
06438153000419Internal U-Turn, TCA19520462023-07-25
06438153000433Z-Turn, right, TCA19520482023-07-25
06438153000440Z-Turn, left, TCA19520492023-07-25
06438153000488Stago STA-R Interface, TCA19520552023-07-25
06438153000549Parallel Bypass, TCA Vitros 5.1 FS19521312023-07-25
06438153000587Parallel Bypass, TCA Beckman Unicel DxI 80019521352023-07-25

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