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Pancreatic Elastase ELISA

Primary DI
04099466112231
Brand
Pancreatic Elastase ELISA
Company
Seramun Diagnostica GmbH
Model
G09038USA
Published
2023-10-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04099466112231PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04099466112231040994661122314099466112231

GMDN Terms#

Term, Definition table
TermDefinition
Pancreatic elastase (PE) IVD, kit, enzyme immunoassay (EIA)A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of pancreatic elastase (PE) in a clinical specimen, using an enzyme immunoassay (EIA) method.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
344006309
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04099466112248Pancreatic Elastase ELISAG090402024-11-21
04099466400116Stool Preparation SetACS-0012024-11-21