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IVD CAPSULE PSP

Primary DI
07649996894021
Brand
IVD CAPSULE PSP
Company
Abionic SA
Model
P02.00026
Device description
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).
Published
2025-02-18
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
SCXImmunoassay For Host Biomarkers Of Sepsis

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
SCXImmunoassay For Host Biomarkers Of SepsisMicrobiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07649996894021PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07649996894021076499968940217649996894021

GMDN Terms#

Term, Definition table
TermDefinition
Pancreatic stone protein (PSP) IVD, kit, fluorescent immunoassayA collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of pancreatic stone protein (PSP) also known as lithostathine-1-alpha or reg-1-alpha, in a clinical specimen, using a fluorescent immunoassay method. It is used to help assess a patient’s risk of developing sepsis.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
485727270
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07649996894090IVD CAPSULE Control PSPP02.000402025-09-29
07649996894106abioSCOPE ControlP02.000452025-09-29
07649996894014abioSCOPEP01.000072025-02-18