IVD CAPSULE PSP

GUDID 07649996894021

The IVD CAPSULE PSP is a single-use, rapid in vitro diagnostic immunofluorescence assay for the semi-quantitative determination of the concentration of pancreatic stone protein (PSP).

Abionic SA

Pancreatic stone protein (PSP) IVD, kit, fluorescent immunoassay

• Primary Device ID: 07649996894021
• NIH Device Record Key: c4161c27-8416-4df0-9b85-766be13e3996
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: IVD CAPSULE PSP
• Version Model Number: P02.00026
• Company DUNS: 485727270
• Company Name: Abionic SA
• 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: true
• 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
• 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	07649996894021 [Primary]

FDA Product Code

• SCX: Immunoassay For Host Biomarkers Of Sepsis

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: 2025-02-26
• Device Publish Date: 2025-02-18

Devices Manufactured by Abionic SA

• 07649996894014 - abioSCOPE: 2025-02-26 The abioSCOPE is a table top diagnostic device that measures analytes in biological samples, using testspecific capsules (IVD CA
• 07649996894021 - IVD CAPSULE PSP: 2025-02-26The IVD CAPSULE PSP is a single-use, rapid in vitro diagnostic immunofluorescence assay for the semi-quantitative determination of the concentration of pancreatic stone protein (PSP).
• 07649996894021 - IVD CAPSULE PSP: 2025-02-26 The IVD CAPSULE PSP is a single-use, rapid in vitro diagnostic immunofluorescence assay for the semi-quantitative determination