FDA.reportPublic FDA data

MP Biomedicals LLC

Primary DI
00817830023228
Brand
MP Biomedicals LLC
Company
Mp Biomedicals, LLC
Model
07596303
Catalog number
07596303
Device description
NEONATAL TRYPSIN MW 2 PLATE ELISA KIT
Published
2023-08-03
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
00817830023228PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817830023228008178300232288178300232280817830023228

GMDN Terms#

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

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
614875644
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00817830023211MP Biomedicals LLC07189105071891052023-08-03
00817830023235MP Biomedicals LLC07596307075963072023-08-03
00817830023006MP Biomedicals LLC06B25501706B2550172023-08-02
00817830023075MP Biomedicals LLC07140202071402022023-08-02
00817830023082MP Biomedicals LLC07140205071402052023-08-02
00817830023099MP Biomedicals LLC07553300075533002023-08-02
00817830023105MP Biomedicals LLC07553303075533032023-08-02
00817830023112MP Biomedicals LLC07553305075533052023-08-02
00817830023129MP Biomedicals LLC07553306075533062023-08-02
00817830023136MP Biomedicals LLC06B25502506B2550252023-08-02
00817830023143MP Biomedicals LLC07152101071521012023-08-02
00817830023150MP Biomedicals LLC07171102071711022023-08-02
00817830023167MP Biomedicals LLC07170102071701022023-08-02
00817830023174MP Biomedicals LLC07170105071701052023-08-02
00817830023181MP Biomedicals LLC07270102072701022023-08-02
00817830023198MP Biomedicals LLC07270105072701052023-08-02
00817830023204MP Biomedicals LLC07189102071891022023-08-02
00817830023013MP Biomedicals LLC07109202071092022023-08-01
00817830023020MP Biomedicals LLC07230102072301022023-08-01
00817830023037MP Biomedicals LLC07138102071381022023-08-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04099466112248Pancreatic Elastase ELISASeramun Diagnostica GmbHJNO2024-11-21
00817830023235MP Biomedicals LLCMp Biomedicals, LLCJNO2023-08-03
03770024321579TRYPS-USCISBIO BIOASSAYSJNO2021-12-07
05400569001411Trypsin-RIADiasource Immunoassays S.A. SAJNO2020-01-29
06438147298716AutoDELFIA Neonatal IRT kitWallac OyJNO2016-02-02
06438147298785AutoDELFIA Neonatal IRT kit Wallac OyJNO2016-02-02
06438147320523GSP Neonatal IRT kitWallac OyJNO2016-01-12