FDA.reportPublic FDA data

HYDROFLEX ELISA

Primary DI
09120052070453
Brand
HYDROFLEX ELISA
Company
Tecan Austria GmbH
Model
30087532 01
Catalog number
30087532
Device description
Microplate washer
Published
2020-09-18
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

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
09120052070453PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
09120052070453091200520704539120052070453

GMDN Terms#

Term, Definition table
TermDefinition
Microplate washer IVD, automatedA mains electricity (AC-powered) laboratory instrument intended to be used for washing microplates containing multiple individual sample wells (i.e., the removal of biological specimen residue, stains, or impurities) by dispensing and aspirating measured volumes of washing solution as part of the processing required to perform an in vitro diagnostic assay. The device is typically programmable and operates with minimal technician involvement and complete automation of all procedural steps.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+18003525128helpdesk-us@tecan.com

Regulatory Flags#

DUNS number
301237509
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
09120052070880MAGELLAN PROMAGELLAN PRO V 7.X2020-01-07
09120052070910MAGELLAN PROMAGELLAN PRO TRACKER V 7.X2020-01-07
09120052070996MAGELLANMAGELLAN V7.X301838892020-12-01
09120052071009MAGELLANMAGELLAN TRACKER V7.X301838902020-12-01
09120052071320USB-STICK MAGELLAN PRO V7.530219868 00302198682023-02-26
09120052071238USB-STICK MAGELLAN V 7.5 SUNRISE+F5030204301 00302043012022-05-26
09120052071504USB-STICK MAGELLAN V 7.530231095 00302310952023-07-07
09120052071184SUNRISE30087502 02300875022023-07-06
09120052071191SUNRISE-RC/ST EVOLYZER30087504 02300875042023-07-06
09120052071207SUNRISE-RC/TW EVOLYZER30087505 02300875052023-07-06
09120052071214SUNRISE-RC/6F EVOLYZER30087506 02300875062023-07-06
09120052071344USB-STICK MAGELLAN PRO V7.530219868 00302198682023-02-26
09120052071351USB-STICK MAGELLAN PRO V7.430220141 00 302201412022-08-17
09120052071146Infinite F50 Plus30183570 00301835702022-05-26
09120052071160Hydroflex Plus30190374 00301903742022-05-26
09120052070521INFINITE 200 PRO30050303 01300503032021-06-22
09120052070460HYDROFLEX EVOLYZER 8CH30087533 01300875332020-09-18
09120052070477HYDROFLEX EVOLYZER 16CH30087534 01300875342020-09-18
09120052070484HYDROFLEX FOR FREEDOM EVO30087535 01300875352020-09-18
09120052070385SUNRISE-RC/ST EVOLYZER30087504 01300875042020-12-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08435389828150SAMPLE PREPARATION KITBIOTECHNOLOGY INSTITUTE SLLXG2026-05-27
00816394021855Helmer ScientificHELMER, INC.LXG2026-05-13
00816394021930Helmer ScientificHELMER, INC.LXG2026-05-13
00816394021947Helmer ScientificHELMER, INC.LXG2026-05-13
00816394021954Helmer ScientificHELMER, INC.LXG2026-05-13
00816394021985Helmer ScientificHELMER, INC.LXG2026-05-13
00816394021992Helmer ScientificHELMER, INC.LXG2026-05-13
00816394022005Helmer ScientificHELMER, INC.LXG2026-05-13
00816394022012Helmer ScientificHELMER, INC.LXG2026-05-13
00816394022050Helmer ScientificHELMER, INC.LXG2026-05-13
00816394022067Helmer ScientificHELMER, INC.LXG2026-05-13
00816394022074Helmer ScientificHELMER, INC.LXG2026-05-13
00816394022081Helmer 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
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
00810100050542KBMEDKB Medical (group), Inc.LXG2025-05-22
00810100050559KBMEDKB Medical (group), Inc.LXG2025-05-22
00810100050603KBMEDKB Medical (group), Inc.LXG2025-05-22
00810100050610KBMEDKB Medical (group), Inc.LXG2025-05-22
00810100051297KBMEDKB Medical (group), Inc.LXG2025-05-22
20885380197861CARDINAL HEALTHCardinal Health 200, LLCLXG2025-04-18