EliA CCP Positive Control 2500/5000 83-0008-81

GUDID 07333066014173

EliA CCP Positive Control 2500/5000

Phadia AB

Plasma protein IVD, control

• Primary Device ID: 07333066014173
• NIH Device Record Key: 5da97d73-47b9-4487-a9f3-88698c45723f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EliA CCP Positive Control 2500/5000
• Version Model Number: 83-0008-81
• Catalog Number: 83-0008-81
• 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

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	07333066014173 [Package]; Contains: 07333066020020; Package: [6 Units]; In Commercial Distribution
GS1	07333066020020 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K061165

FDA Product Code

• NHX: ANTIBODIES, ANTI-CYCLIC CITRULLINATED PEPTIDE (CCP)

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: 2019-04-08
• Device Publish Date: 2019-03-29

Devices Manufactured by Phadia AB

• 07333066015507 - EliA CCP Well: 2026-02-06 EliA CCP Well
• 07333066023908 - EliA IgG Calibrator Well: 2026-02-06 EliA IgG Calibrator Well
• 07333066023939 - EliA Dummy Well: 2026-02-06 EliA Dummy Well
• 07333066023977 - EliA IgA Calibrator Well: 2026-02-06 EliA IgA Calibrator Well
• 07333066024035 - EliA IgM Calibrator Well: 2026-02-06 EliA IgM Calibrator Well
• 07333066024110 - EliA RF IgM Well: 2026-02-06 EliA RF IgM Well
• 07333066024134 - EliA RF IgA Well: 2026-02-06 EliA RF IgA Well
• 07333066021621 - Phadia 2500+ LAS Connector: 2023-11-28 Phadia 2500+ LAS Connector