EliA M2 Positive Control 2500/5000 83-0015-01

GUDID 07333066014333

EliA M2 Positive Control 2500/5000

Phadia AB

Plasma protein IVD, control

• Primary Device ID: 07333066014333
• NIH Device Record Key: 5a8c9dee-98ed-49aa-a4cb-ceaf2a76030a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EliA M2 Positive Control 2500/5000
• Version Model Number: 83-0015-01
• Catalog Number: 83-0015-01
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• 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
• 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
• Phone: +469999999999
• Email: xx@xx.xx
• Phone: +469999999999
• Email: xx@xx.xx
• Phone: +469999999999
• Email: xx@xx.xx
• Phone: +469999999999
• Email: xx@xx.xx

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	07333066013527 [Primary]
GS1	07333066014333 [Package]; Contains: 07333066013527; Package: [6 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K181556

FDA Product Code

• DBM: ANTIMITOCHONDRIAL ANTIBODY, INDIRECT IMMUNOFLUORESCENT, ANTIGEN, CONTROL
• JJY: Multi-analyte controls, all kinds (assayed)

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: 2020-12-17
• Device Publish Date: 2020-12-09

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• 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