Phadia 100 12-3500-02

GUDID 07333066000992

Phadia 100

Phadia AB

Fluorescent immunoassay analyser IVD, laboratory, automated

• Primary Device ID: 07333066000992
• NIH Device Record Key: d8e1f31b-a65c-426e-8601-4300d26f6ce5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Phadia 100
• Version Model Number: 12-3500-02
• Catalog Number: 12-3500-02
• 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	07333066000992 [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

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• 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