AutoDELFIA Neonatal 17α-OH-progesterone kit B024-01C

GUDID 06438147292479

For the quantitative determination of 17α-OH-progesterone (17-OHP) in dried blood.

Wallac Oy

17-Hydroxyprogesterone IVD, kit, fluorescent immunoassay

• Primary Device ID: 06438147292479
• NIH Device Record Key: b5be0b1a-6594-46be-bfb7-1e5848903db5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AutoDELFIA Neonatal 17α-OH-progesterone kit
• Version Model Number: B024-01C
• Catalog Number: B024-01C
• 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: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	06438147292479 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K081922

FDA Product Code

• JLX: Radioimmunoassay, 17-Hydroxyprogesterone

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: 2018-12-17
• Device Publish Date: 2018-11-16

On-Brand Devices [AutoDELFIA Neonatal 17α-OH-progesterone kit]

• 06438147292523: For the quantitative determination of 17α-OH-progesterone (17-OHP) in dried blood.
• 06438147292486: For the quantitative determination of 17α-OH-progesterone (17-OHP) in dried blood.
• 06438147292479: For the quantitative determination of 17α-OH-progesterone (17-OHP) in dried blood.