EliA Sample Diluent 83-0009-21

GUDID 07333066020402

EliA Sample Diluent

Phadia AB

Plasma protein IVD, reagent Plasma protein IVD, reagent Plasma protein IVD, reagent Plasma protein IVD, reagent Plasma protein IVD, reagent Plasma protein IVD, reagent Plasma protein IVD, reagent Plasma protein IVD, reagent Plasma protein IVD, reagent Plasma protein IVD, reagent Plasma protein IVD, reagent Plasma protein IVD, reagent Plasma protein IVD, reagent Plasma protein IVD, reagent

• Primary Device ID: 07333066020402
• NIH Device Record Key: 97fe901b-92d1-409f-8329-94d5897e357b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EliA Sample Diluent
• Version Model Number: 83-0009-21
• Catalog Number: 83-0009-21
• 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: 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	07333066013206 [Primary]
GS1	07333066020402 [Package]; Contains: 07333066013206; 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

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

On-Brand Devices [EliA Sample Diluent]

• 07333066013800: EliA Sample Diluent
• 07333066013657: EliA Sample Diluent
• 07333066020402: EliA Sample Diluent