EliA SmDP Well DECC056240

GUDID 07333066010885

EliA SmDP Well

Phadia AB

Smith antibody (anti-Sm) IVD, kit, fluorescent immunoassay

• Primary Device ID: 07333066010885
• NIH Device Record Key: 7b79b2e7-e7dc-43a1-95ae-29d1dc861999
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EliA SmDP Well
• Version Model Number: DECC056240
• Catalog Number: DECC056240
• 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

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	07333066010885 [Package]; Contains: 07333066014838; Package: [2 Units]; In Commercial Distribution
GS1	07333066014838 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K132631

FDA Product Code

• LKP: ANTI-SM ANTIBODY, ANTIGEN AND CONTROL

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-23

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