FDA.reportPublic FDA data

PROFI BLOT T48

Primary DI
09120052070514
Brand
PROFI BLOT T48
Company
Tecan Austria GmbH
Model
09120052070514
Catalog number
30087538
Published
2020-09-04
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
KPASlide Stainer, Automated

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KPASlide Stainer, AutomatedPathology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
09120052070514PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
09120052070514091200520705149120052070514

GMDN Terms#

Term, Definition table
TermDefinition
Blot processor IVDA mains electricity (AC-powered) laboratory instrument intended to be used for the processing of a prepared clinical specimen with an immobilized probe on a solid phase (e.g. blotting membrane or gel sheet) for blot assays (e.g. line assays, Western, Southern and/or Northern blot). It typically performs pre-analytical steps including (but not limited to) reagent dispensing, incubation (with or without heating), agitation and washing. The device does not include a detector and is not intended to perform qualitative and/or quantitative measurements.

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
09120052070453HYDROFLEX ELISA30087532 01300875322020-09-18
09120052070460HYDROFLEX EVOLYZER 8CH30087533 01300875332020-09-18
09120052070477HYDROFLEX EVOLYZER 16CH30087534 01300875342020-09-18
09120052070484HYDROFLEX FOR FREEDOM EVO30087535 01300875352020-09-18

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