FDA.reportPublic FDA data

Interface, TCA ImmunoCap 1000

Primary DI
06438153000655
Brand
Interface, TCA ImmunoCap 1000
Company
Thermo Fisher Scientific Oy
Model
1
Catalog number
952243
Device description
Interface, TCA ImmunoCap 1000 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
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

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
06438153000655PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06438153000655064381530006556438153000655

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.

Regulatory Flags#

DUNS number
540096708
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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
06438153000471Sysmex HST Interface, TCA19520542023-07-25
06438153000488Stago STA-R Interface, TCA19520552023-07-25
06438153000549Parallel Bypass, TCA Vitros 5.1 FS19521312023-07-25

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Primary DI, Brand, Company table
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00816394022371Helmer ScientificHELMER, INC.LXG2026-10-14
00816394022388Helmer ScientificHELMER, INC.LXG2026-10-14
00816394022395Helmer ScientificHELMER, INC.LXG2026-10-14
00816394022432Helmer ScientificHELMER, INC.LXG2026-10-14
00816394022449Helmer ScientificHELMER, INC.LXG2026-10-14
00816394022456Helmer ScientificHELMER, INC.LXG2026-10-14
00816394022463Helmer ScientificHELMER, INC.LXG2026-10-14
04038917124614TUBE SEGMENT OPENER ASM TB 75/12 PSSarstedt Aktiengesellschaft & Co.KGLXG2026-07-21
04038917390835TUBE SEGMENT OPENER ASM TB 75/ 12 PS CBSarstedt Aktiengesellschaft & Co.KGLXG2026-07-21
04038917253437Archiving CapSarstedt Aktiengesellschaft & Co.KGLXG2026-07-20
15099590812478DxUBeckman Coulter, Inc.LXG2026-06-24
08435389828150SAMPLE PREPARATION KITBIOTECHNOLOGY INSTITUTE SLLXG2026-05-27
00816394021855Helmer ScientificHELMER, INC.LXG2026-05-13
00816394021930Helmer ScientificHELMER, INC.LXG2026-05-13
15099590695743iChemVELOCITYBECKMAN COULTER IRELAND INC.LXG2026-04-27
09120123910022Anchor Tips, 300uLSTRATEC Consumables GmbHLXG2026-01-14
26974573531033CellproSuzhou CellPro Biotechnology Co., Ltd.LXG2025-11-21
10818207025071Endocator Starter KitVista DentalLXG2025-11-07
10818207025088Endocator Swabs (20pk)Vista DentalLXG2025-11-07
10849832025815Leica BiosystemsLeica Biosystems Richmond, Inc.LXG2025-07-23
10849832024238Leica BiosystemsLeica Biosystems Richmond, Inc.LXG2025-07-20
10849832024276Leica BiosystemsLeica Biosystems Richmond, Inc.LXG2025-07-20
10849832027055Leica BiosystemsLeica Biosystems Richmond, Inc.LXG2025-07-20
00810100050269KBMEDKB Medical (group), Inc.LXG2025-05-22
00810100050283KBMEDKB Medical (group), Inc.LXG2025-05-22
00810100050306KBMEDKB Medical (group), Inc.LXG2025-05-22
00810100050511KBMEDKB Medical (group), Inc.LXG2025-05-22
00810100050528KBMEDKB Medical (group), Inc.LXG2025-05-22
00810100050535KBMEDKB Medical (group), Inc.LXG2025-05-22