Phadia 5000 12-4000-00

GUDID 07333066001043

Phadia 5000

Phadia AB

Fluorescent immunoassay analyser IVD, laboratory, automated

• Primary Device ID: 07333066001043
• NIH Device Record Key: 4275c81e-7aea-466c-9eb1-247beb08aaf3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Phadia 5000
• Version Model Number: 12-4000-00
• Catalog Number: 12-4000-00
• Company DUNS: 354019424
• Company Name: Phadia AB
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• 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: false
• 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: +469999999999
• Email: xx@xx.xx
• Phone: +469999999999
• Email: xx@xx.xx
• Phone: +469999999999
• Email: xx@xx.xx
• Phone: +469999999999
• Email: xx@xx.xx
• Phone: +469999999999
• Email: xx@xx.xx
• Phone: +469999999999
• Email: xx@xx.xx
• Phone: +469999999999
• Email: xx@xx.xx
• Phone: +469999999999
• Email: xx@xx.xx
• Phone: +469999999999
• Email: xx@xx.xx
• Phone: +469999999999
• Email: xx@xx.xx
• Phone: +469999999999
• Email: xx@xx.xx
• Phone: +469999999999
• Email: xx@xx.xx
• Phone: +469999999999
• Email: xx@xx.xx
• Phone: +469999999999
• Email: xx@xx.xx
• Phone: +469999999999
• Email: xx@xx.xx

Device Identifiers

Device Issuing Agency	Device ID
GS1	07333066001043 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K051218

FDA Product Code

• DHB: SYSTEM, TEST, RADIOALLERGOSORBENT (RAST) IMMUNOLOGICAL

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-23

Devices Manufactured by Phadia AB

• 07333066021621 - Phadia 2500+ LAS Connector: 2023-11-28 Phadia 2500+ LAS Connector
• 07333066003023 - ImmunoCAP Dummy ImmunoCAP: 2023-07-18 ImmunoCAP Dummy ImmunoCAP
• 07333066005454 - ImmunoCAP Allergen f416, Allergen component rTri a 19 Omega-5 Gliadin, Wheat: 2022-12-01 ImmunoCAP Allergen f416, Allergen component rTri a 19 Omega-5 Gliadin, Wheat
• 07333066010922 - ImmunoCAP Allergen f433, Allergen component rTri a 14 LTP, Wheat: 2022-12-01 ImmunoCAP Allergen f433, Allergen component rTri a 14 LTP, Wheat
• 07333066010991 - ImmunoCAP Allergen f98, Gliadin: 2022-12-01 ImmunoCAP Allergen f98, Gliadin
• 07333066021706 - ImmunoCAP Allergen f449, Allergen component rSes i 1 Sesame seed: 2022-12-01 ImmunoCAP Allergen f449, Allergen component rSes i 1 Sesame seed
• 07333066014876 - EliA Ro60 Well: 2022-09-22 EliA Ro60 Well
• 07333066014906 - EliA Ro52 Well: 2022-09-22 EliA Ro52 Well