ImmunoCAP Tryptase Curve Control 1 34-2311-12

GUDID 07333066000275

ImmunoCAP Tryptase Curve Control 1

Phadia AB

Tryptase IVD, kit, enzyme immunoassay (EIA) Mast cell protease IVD, kit, enzyme immunoassay (EIA) Mast cell protease IVD, kit, enzyme immunoassay (EIA) Mast cell protease IVD, kit, enzyme immunoassay (EIA) Mast cell protease IVD, kit, enzyme immunoassay (EIA) Mast cell protease IVD, kit, enzyme immunoassay (EIA) Mast cell protease IVD, kit, enzyme immunoassay (EIA) Mast cell protease IVD, kit, enzyme immunoassay (EIA) Mast cell protease IVD, kit, enzyme immunoassay (EIA) Mast cell protease IVD, kit, enzyme immunoassay (EIA) Mast cell protease IVD, kit, enzyme immunoassay (EIA) Mast cell protease IVD, kit, enzyme immunoassay (EIA) Mast cell protease IVD, kit, enzyme immunoassay (EIA) Mast cell protease IVD, kit, enzyme immunoassay (EIA) Mast cell protease IVD, kit, enzyme immunoassay (EIA) Mast cell protease IVD, kit, enzyme immunoassay (EIA) Mast cell protease IVD, kit, enzyme immunoassay (EIA) Mast cell protease IVD, kit, enzyme immunoassay (EIA)

• Primary Device ID: 07333066000275
• NIH Device Record Key: 17df81a9-2e7e-4cb1-9580-3cec8361e217
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ImmunoCAP Tryptase Curve Control 1
• Version Model Number: 34-2311-12
• Catalog Number: 34-2311-12
• 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

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	07333066000275 [Package]; Contains: 07333066011998; Package: [6 Units]; In Commercial Distribution
GS1	07333066011998 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• deNovo: DEN120001

FDA Product Code

• OYL: Tryptase assay system

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: 2019-03-11
• Device Publish Date: 2019-02-15

On-Brand Devices [ImmunoCAP Tryptase Curve Control 1]

• 07333066000916: ImmunoCAP Tryptase Curve Control 1
• 07333066000275: ImmunoCAP Tryptase Curve Control 1