FDA.reportPublic FDA data

MP Biomedicals LLC

Primary DI
00817830023099
Brand
MP Biomedicals LLC
Company
Mp Biomedicals, LLC
Model
07553300
Catalog number
07553300
Device description
NEONATAL GALACTOSE MW 2 PLATE ENZYME ASSAY KIT (WITHOUT MEMBRANE)
Published
2023-08-02
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
JIAEnzymatic Methods, Galactose

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JIAEnzymatic Methods, GalactoseClinical Chemistry1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K951329000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K951329000IMMUCHEM GAL-MW EAIcn Pharmaceuticals, Inc.1995-11-09JIA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00817830023099PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817830023099008178300230998178300230990817830023099

GMDN Terms#

Term, Definition table
TermDefinition
Galactose IVD, kit, enzyme fluorescenceA collection of reagents and other associated materials intended to be used for the quantitative measurement of galactose in a clinical specimen, using an enzyme fluorescence method.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
614875644
Device count
1
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
00817830023228MP Biomedicals LLC07596303075963032023-08-03
00817830023235MP Biomedicals LLC07596307075963072023-08-03
00817830023006MP Biomedicals LLC06B25501706B2550172023-08-02
00817830023075MP Biomedicals LLC07140202071402022023-08-02
00817830023082MP Biomedicals LLC07140205071402052023-08-02
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
00817830023105MP Biomedicals LLCMp Biomedicals, LLCJIA2023-08-02
00817830023112MP Biomedicals LLCMp Biomedicals, LLCJIA2023-08-02
00817830023129MP Biomedicals LLCMp Biomedicals, LLCJIA2023-08-02
00840239014863Galactose (with Membrane Plate) ELISADRG International IncJIA2021-06-07
00840239014870Galactose (without Membrane Plate) ELISADRG International IncJIA2021-06-07
00840239014887Galactose (with Membrane Plate) ELISADRG International IncJIA2021-06-07
00840239014894Galactose (without Membrane Plate) ELISADRG International IncJIA2021-06-07
06438147367917GSP Neonatal Total Galactose kitWallac OyJIA2021-06-04
00725609000595SPOTCHECKASTORIA-PACIFIC, INC.JIA2020-12-17
06438147275281Neonatal Total Galactose kit Wallac OyJIA2017-05-02
06438147328031GSP Neonatal Total Galactose Kit Wallac OyJIA2017-05-02
00725609000090SPOTCHECKASTORIA-PACIFIC, INC.JIA2016-10-14
00725609000106SPOTCHECKASTORIA-PACIFIC, INC.JIA2016-10-14
00725609000199AccuwellASTORIA-PACIFIC, INC.JIA2016-10-14