FDA.reportPublic FDA data

MP Biomedicals LLC

Primary DI
00817830023129
Brand
MP Biomedicals LLC
Company
Mp Biomedicals, LLC
Model
07553306
Catalog number
07553306
Device description
NEONATAL GALACTOSE MW 10 PLATE ENZYME ASSAY KIT (WITH 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
00817830023129PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817830023129008178300231298178300231290817830023129

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
00817830023099MP Biomedicals LLC07553300075533002023-08-02
00817830023105MP Biomedicals LLC07553303075533032023-08-02
00817830023112MP Biomedicals LLC07553305075533052023-08-02
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
00817830023099MP Biomedicals LLCMp Biomedicals, LLCJIA2023-08-02
00817830023105MP Biomedicals LLCMp Biomedicals, LLCJIA2023-08-02
00817830023112MP 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