AutoDELFIA hCG kit B007-101

GUDID 06438147009336

Time-resolved fluoroimmunoassay for the quantitative determination of human chorionic gonadotropin (hCG).

Wallac Oy

Total human chorionic gonadotropin (HCG) IVD, kit, fluorescent immunoassay Total human chorionic gonadotropin IVD, kit, fluorescent immunoassay Total human chorionic gonadotropin IVD, kit, fluorescent immunoassay Total human chorionic gonadotropin IVD, kit, fluorescent immunoassay Total human chorionic gonadotropin IVD, kit, fluorescent immunoassay Total human chorionic gonadotropin IVD, kit, fluorescent immunoassay Total human chorionic gonadotropin IVD, kit, fluorescent immunoassay Total human chorionic gonadotropin IVD, kit, fluorescent immunoassay Total human chorionic gonadotropin IVD, kit, fluorescent immunoassay Total human chorionic gonadotropin IVD, kit, fluorescent immunoassay Total human chorionic gonadotropin IVD, kit, fluorescent immunoassay Total human chorionic gonadotropin IVD, kit, fluorescent immunoassay Total human chorionic gonadotropin IVD, kit, fluorescent immunoassay Total human chorionic gonadotropin IVD, kit, fluorescent immunoassay Total human chorionic gonadotropin IVD, kit, fluorescent immunoassay Total human chorionic gonadotropin IVD, kit, fluorescent immunoassay

• Primary Device ID: 06438147009336
• NIH Device Record Key: 9a95d0f2-4d10-4475-9ff7-a8e9f13cb5f3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AutoDELFIA hCG kit
• Version Model Number: B007-101
• Catalog Number: B007-101
• Company DUNS: 540156544
• Company Name: Wallac Oy
• 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: false
• OTC Over-The-Counter: false

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	06438147009336 [Primary]

FDA Product Code

• JHJ: Agglutination Method, Human Chorionic Gonadotropin

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-02-11

On-Brand Devices [AutoDELFIA hCG kit ]

• 06438147009343: Time-resolved fluoroimmunoassay for the quantitative determination of human chorionic gonadotrop
• 06438147009336: Time-resolved fluoroimmunoassay for the quantitative determination of human chorionic gonadotrop