ImmunoCAP Total IgE Control LMH 10-9447-01

GUDID 07333066019642

Contains two vials of each Total IgE Control (L, M, H) for the ImmunoCAP Total IgE method.

Phadia AB

Plasma protein IVD, control

• Primary Device ID: 07333066019642
• NIH Device Record Key: 100def06-fe8e-4e79-8ecb-b6cae27f14bb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ImmunoCAP Total IgE Control LMH
• Version Model Number: 10-9447-01
• Catalog Number: 10-9447-01
• 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: true
• 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

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	07333066019642 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K133404

FDA Product Code

• DGC: IGE, ANTIGEN, ANTISERUM, 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: 2019-04-03
• Device Publish Date: 2019-03-26

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