Sofia 20352

GUDID 50014613338776

Sofia 2 Campylobacter FIA

QUIDEL CARDIOVASCULAR INC.

Multiple Campylobacter species antibody IVD, kit, fluorescent immunoassay

• Primary Device ID: 50014613338776
• NIH Device Record Key: 0fb2d791-c97a-4f93-93c3-44403a8c0fa3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sofia
• Version Model Number: 20352
• Catalog Number: 20352
• Company DUNS: 080890141
• Company Name: QUIDEL CARDIOVASCULAR INC.
• 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

Operating and Storage Conditions

• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze, Store out of direct sunlight
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze, Store out of direct sunlight
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze, Store out of direct sunlight
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze, Store out of direct sunlight
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze, Store out of direct sunlight
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze, Store out of direct sunlight
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze, Store out of direct sunlight
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze, Store out of direct sunlight
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze, Store out of direct sunlight
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze, Store out of direct sunlight

Device Identifiers

Device Issuing Agency	Device ID
GS1	30014613338772 [Primary]
GS1	50014613338776 [Package]; Contains: 30014613338772; Package: Case [12 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K211342

FDA Product Code

• LQP: CAMPYLOBACTER SPP.

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: 2025-11-26
• Device Publish Date: 2025-11-18

Devices Manufactured by QUIDEL CARDIOVASCULAR INC.

• 50014613338776 - Sofia: 2025-11-26Sofia 2 Campylobacter FIA
• 50014613338776 - Sofia: 2025-11-26 Sofia 2 Campylobacter FIA
• 30014613338109 - Triage: 2025-06-26 Triage TOX Drug Screen, 94600
• 30014613338116 - Triage: 2025-05-23 Triage TOX Drug Screen, 94600 Control 1
• 30014613338123 - Triage: 2025-05-23 Triage TOX Drug Screen, 94600 Control 2
• 30014613337928 - Triage: 2020-04-03 Triage Cardiac Panel (OUS)
• 30014613338024 - Triage: 2019-06-06 Triage Troponin I Test (OUS)
• 30014613337089 - Triage: 2019-03-22 Triage Total 3 Control 1
• 30014613337096 - Triage: 2019-03-22 Triage Total 3 Control 2