FDA.reportPublic FDA data

Trypsin-RIA

Primary DI
05400569001411
Brand
Trypsin-RIA
Company
Diasource Immunoassays S.A. SA
Model
KIPCE07
Device description
Trypsin-RIA
Published
2020-01-29
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
JNON-BENZOYL-L-ARGININE ETHYL ESTER (U.V.), TRYPSIN

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JNON-Benzoyl-L-Arginine Ethyl Ester (U.V.), TrypsinClinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05400569001411PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05400569001411054005690014115400569001411

GMDN Terms#

Term, Definition table
TermDefinition
Trypsin IVD, kit, radioimmunoassayA collection of reagents and other associated materials intended to be used for the quantitative measurement of trypsin in a clinical specimen, using a radioimmunoassay method.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
458777323
Device count
1
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05400569000209IGF-1 ELISAKAP15812020-09-11
05400569000414KIP1131KIP11312020-09-11
05400569000520IGF-1-RIA-CTKIP15882020-09-11
05400569000407hGH-IRMAKIP10812020-01-15
05400569000117INS ELISAKAP12512020-01-10
05400569000087IGFBP-3 ElisaKAP11712020-01-09
05400569000346ANDROSTENEDIONE-RIA-CTKIP04512020-10-05
05400569000452LHsp-IRMAKIP13112020-10-05
05400569000674Estrone-RIA-CTKIPI91002020-09-16
05400569000360E2 RIA CTKIP06292020-09-15
0540056900065011-DESOXYCORTISOL-RIA-CTKIPI200002020-09-15
05400569000049C-PEP-EASIAKPA04012020-09-14
05400569000377FSH IRMAKIP08412020-09-14
05400569000865Androstenedione-ELISAKAPD32652020-09-14
05400569000490PROG-RIA-CTKIP14582020-09-11
05400569000322C-PEP II-RIA-CTKIP04092020-01-15
05400569000353DHEA-S-RIA-CTKIP04812020-01-15
05400569000438INS-IRMAKIP1251/KIP12542020-01-15
0540056900047617OHP RIA CTKIP14092020-01-15
05400569000483PRL-IRMAKIP14412020-01-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04099466112248Pancreatic Elastase ELISASeramun Diagnostica GmbHJNO2024-11-21
00817830023228MP Biomedicals LLCMp Biomedicals, LLCJNO2023-08-03
00817830023235MP Biomedicals LLCMp Biomedicals, LLCJNO2023-08-03
03770024321579TRYPS-USCISBIO BIOASSAYSJNO2021-12-07
06438147298716AutoDELFIA Neonatal IRT kitWallac OyJNO2016-02-02
06438147298785AutoDELFIA Neonatal IRT kit Wallac OyJNO2016-02-02
06438147320523GSP Neonatal IRT kitWallac OyJNO2016-01-12