FDA.reportPublic FDA data

TENDIGO

Primary DI
05414470804122
Brand
TENDIGO
Company
Fujirebio Europe
Model
80412
Device description
Instrument
Published
2020-02-24
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
JJEAnalyzer, Chemistry (Photometric, Discrete), For Clinical Use

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JJEAnalyzer, Chemistry (Photometric, Discrete), For Clinical UseClinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05414470804122PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05414470804122054144708041225414470804122

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Height15Inch
Length27Inch
Width18Inch

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature15 Degrees Celsius30 Degrees Celsius
Storage Environment Temperature-25 Degrees Celsius50 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+32093291329info@fujirebio.com

Regulatory Flags#

DUNS number
297346645
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
05414470156870LiRAS for LiPA HCV v1156872025-05-30
05414470816590INNO-LiPA HCV 2.0 Genotyping816592025-05-30
05414470816606INNO-LiPA HCV 2.0 Amp816602025-05-30
05414470816613INNO-LiPA HCV 2.0 Control816612025-05-30
05414470816620INNO-LiPA HCV 2.0 Genotyping816622025-05-30
05414470816637INNO-LiPA HCV 2.0 Amp816632025-05-30
05414470815500Lumipulse G pTau 217 Plasma Immunoreaction Cartridges815502025-06-16
05414470815579Lumipulse G pTau 217 Plasma Calibrators815572025-06-16
05414470815586Lumipulse pTau 217 Plasma Controls815582025-06-16
05414470815593Lumipulse B-Amyloid Plasma Controls815592025-06-16
05414470804214TENDIGO Disposable TraysCat No. 804212022-09-14
05414470806287Auto-LiPA 48 806282020-02-24
05414470806294Auto-LIA 48806292020-02-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810053950128NOVEOS Brazil Nut, Bertholletia excelsaHYCOR BIOMEDICAL LLCJJE2026-05-29
00810053950203NOVEOS Coconut, Cocos nuciferaHYCOR BIOMEDICAL LLCJJE2026-05-29
00810053950210NOVEOS Tuna, Thunnus sp.HYCOR BIOMEDICAL LLCJJE2026-05-29
00810053950227NOVEOS Salmon, Salmo salarHYCOR BIOMEDICAL LLCJJE2026-05-29
00810053950265NOVEOS Egg Yolk, Gallus gallusHYCOR BIOMEDICAL LLCJJE2026-05-29
00810053950340NOVEOS Pecan Nut, Carya illinoensisHYCOR BIOMEDICAL LLCJJE2026-05-29
00810053950364NOVEOS Pistachio Nut, Pistacia veraHYCOR BIOMEDICAL LLCJJE2026-05-29
00810053950418NOVEOS Oyster, Ostrea edulisHYCOR BIOMEDICAL LLCJJE2026-05-29
00816879023794NOVEOS Brazil Nut, Bertholletia excelsaHYCOR BIOMEDICAL LLCJJE2026-05-29
00816879023824NOVEOS Tuna, Thunnus sp.HYCOR BIOMEDICAL LLCJJE2026-05-29
00816879023886NOVEOS Pistachio Nut, Pistacia veraHYCOR BIOMEDICAL LLCJJE2026-05-29
00816879024548NOVEOS Salmon, Salmo salarHYCOR BIOMEDICAL LLCJJE2026-05-29
00816879024760NOVEOS Pecan Nut, Carya illinoensisHYCOR BIOMEDICAL LLCJJE2026-05-29
00816879025057NOVEOS Oyster, Ostrea edulisHYCOR BIOMEDICAL LLCJJE2026-05-29
00816879025149NOVEOS Egg Yolk, Gallus gallusHYCOR BIOMEDICAL LLCJJE2026-05-29
00816879027372NOVEOS Coconut, Cocos nuciferaHYCOR BIOMEDICAL LLCJJE2026-05-29
06947145541781MAGLUMI X3 Fully-auto chemiluminescence immunoassay analyzerShenzhen New Industries Biomedical Engineering Co., Ltd.JJE2026-05-15
00380740225186ARCHITECTABBOTT LABORATORIESJJE2026-05-14
00380740225193ARCHITECTABBOTT LABORATORIESJJE2026-05-14
07613336224397cobas ISE neo 1800 analytical unitRoche Diagnostics GmbHJJE2026-04-03
07613336200544cobas c 703 analytical unitRoche Diagnostics GmbHJJE2026-03-20
07613336220191cobas pro SBL c 703Roche Diagnostics GmbHJJE2026-03-20
00199874508153Spiral LaboratoriesSOCIETE ANONYME DE FABRICATION D'APPAREILS SCIENTIFIQUESJJE2026-02-10
00380740023386ARCHITECTABBOTT LABORATORIESJJE2026-01-24
06944904084459Chemistry AnalyzerShenzhen Mindray Bio-Medical Electronics Co., Ltd.JJE2026-01-23
00810053950098NOVEOS Peanut, Arachis hypogaeaHYCOR BIOMEDICAL LLCJJE2026-01-22
00810053950272NOVEOS Bos d 4 α-lactalbumin, MilkHYCOR BIOMEDICAL LLCJJE2026-01-22
00810053950289NOVEOS Bos d 5 b-lactoglobulin, MilkHYCOR BIOMEDICAL LLCJJE2026-01-22
00810053950388NOVEOS Gal d 2 Ovalbumin, EggHYCOR BIOMEDICAL LLCJJE2026-01-22
00816879023565NOVEOS Peanut, Arachis hypogaeaHYCOR BIOMEDICAL LLCJJE2026-01-22