TENDIGO
GUDID 05414470804122
Instrument
Fujirebio Europe
Blot processor IVD| Primary Device ID | 05414470804122 |
| NIH Device Record Key | 023d5073-6e02-4b57-9305-b23b2d5bf104 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | TENDIGO |
| Version Model Number | 80412 |
| Company DUNS | 297346645 |
| Company Name | Fujirebio Europe |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | false |
| Serial Number | true |
| Manufacturing Date | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
| Phone | +32093291329 |
| info@fujirebio.com | |
| Phone | +32093291329 |
| info@fujirebio.com | |
| Phone | +32093291329 |
| info@fujirebio.com | |
| Phone | +32093291329 |
| info@fujirebio.com | |
| Phone | +32093291329 |
| info@fujirebio.com | |
| Phone | +32093291329 |
| info@fujirebio.com | |
| Phone | +32093291329 |
| info@fujirebio.com | |
| Phone | +32093291329 |
| info@fujirebio.com | |
| Phone | +32093291329 |
| info@fujirebio.com | |
| Phone | +32093291329 |
| info@fujirebio.com | |
| Phone | +32093291329 |
| info@fujirebio.com | |
| Phone | +32093291329 |
| info@fujirebio.com | |
| Phone | +32093291329 |
| info@fujirebio.com | |
| Phone | +32093291329 |
| info@fujirebio.com | |
| Phone | +32093291329 |
| info@fujirebio.com | |
| Phone | +32093291329 |
| info@fujirebio.com | |
| Phone | +32093291329 |
| info@fujirebio.com | |
| Phone | +32093291329 |
| info@fujirebio.com |
Device Dimensions
| Height | 15 Inch |
| Length | 27 Inch |
| Width | 18 Inch |
| Height | 15 Inch |
| Length | 27 Inch |
| Width | 18 Inch |
| Height | 15 Inch |
| Length | 27 Inch |
| Width | 18 Inch |
| Height | 15 Inch |
| Length | 27 Inch |
| Width | 18 Inch |
| Height | 15 Inch |
| Length | 27 Inch |
| Width | 18 Inch |
| Height | 15 Inch |
| Length | 27 Inch |
| Width | 18 Inch |
| Height | 15 Inch |
| Length | 27 Inch |
| Width | 18 Inch |
| Height | 15 Inch |
| Length | 27 Inch |
| Width | 18 Inch |
| Height | 15 Inch |
| Length | 27 Inch |
| Width | 18 Inch |
| Height | 15 Inch |
| Length | 27 Inch |
| Width | 18 Inch |
| Height | 15 Inch |
| Length | 27 Inch |
| Width | 18 Inch |
| Height | 15 Inch |
| Length | 27 Inch |
| Width | 18 Inch |
| Height | 15 Inch |
| Length | 27 Inch |
| Width | 18 Inch |
| Height | 15 Inch |
| Length | 27 Inch |
| Width | 18 Inch |
| Height | 15 Inch |
| Length | 27 Inch |
| Width | 18 Inch |
| Height | 15 Inch |
| Length | 27 Inch |
| Width | 18 Inch |
| Height | 15 Inch |
| Length | 27 Inch |
| Width | 18 Inch |
| Height | 15 Inch |
Operating and Storage Conditions
| Storage Environment Temperature | Between -25 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between -25 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between -25 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between -25 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between -25 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between -25 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between -25 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between -25 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between -25 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between -25 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between -25 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between -25 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between -25 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between -25 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between -25 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between -25 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between -25 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between -25 Degrees Celsius and 50 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 05414470804122 [Primary] |
FDA Product Code
| JJE | Analyzer, Chemistry (Photometric, Discrete), For Clinical Use |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-03-03 |
| Device Publish Date | 2020-02-24 |
Devices Manufactured by Fujirebio Europe
| 05414470815500 - Lumipulse G pTau 217 Plasma Immunoreaction Cartridges | 2025-06-24 Lumipulse G pTau 217 Plasma Immunoreaction Cartridges 3x14T, IVD-US |
| 05414470815579 - Lumipulse G pTau 217 Plasma Calibrators | 2025-06-24 Lumipulse G pTau 217 Plasma Calibrators 1x5C, IVD-US |
| 05414470815586 - Lumipulse pTau 217 Plasma Controls | 2025-06-24 Lumipulse pTau 217 Plasma Controls 2x2C, IVD-US |
| 05414470815593 - Lumipulse B-Amyloid Plasma Controls | 2025-06-24 Lumipulse B-Amyloid Plasma Controls 2x2C, IVD-US |
| 05414470156870 - LiRAS for LiPA HCV v1 | 2025-06-09 |
| 05414470816590 - INNO-LiPA HCV 2.0 Genotyping | 2025-06-09 |
| 05414470816606 - INNO-LiPA HCV 2.0 Amp | 2025-06-09 |
| 05414470816613 - INNO-LiPA HCV 2.0 Control | 2025-06-09 |
Trademark Results [TENDIGO]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 TENDIGO 79152459 4766494 Live/Registered |
Fujirebio Europe NV 2014-07-02 |
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