FDA.reportPublic FDA data

MP Biomedicals LLC

Primary DI
00817830023143
Brand
MP Biomedicals LLC
Company
Mp Biomedicals, LLC
Model
07152101
Catalog number
07152101
Device description
DOUBLE ANTIBODY GLUCAGON 125I 50 TUBE KIT
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
JMERadioimmunoassay, Glucagon

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JMERadioimmunoassay, GlucagonClinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00817830023143PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817830023143008178300231438178300231430817830023143

GMDN Terms#

Term, Definition table
TermDefinition
Glucagon IVD, kit, enzyme immunoassay (EIA)A collection of reagents and other associated materials intended to be used for the quantitative measurement of glucagon in a clinical specimen, using an enzyme immunoassay (EIA) 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
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
00817830023129MP Biomedicals LLC07553306075533062023-08-02
00817830023136MP Biomedicals LLC06B25502506B2550252023-08-02
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
B24211GLUHUE010Glucagon ELISAAMERICAN LABORATORY PRODUCTS COMPANY, LTD.JME2024-10-23
B261CANGLN3900DBC Glucagon ELISADiagnostics Biochem Canada IncJME2024-10-10
07350108630122Mercodia Glucagon ELISAMercodia ABJME2020-10-01
B24238GLUHUR1000Glucagon RIAAMERICAN LABORATORY PRODUCTS COMPANY, LTD.JME2020-06-02
07350108630115Mercodia Glucagon ELISAMercodia ABJME2020-04-08
05400569003019Glucagon - RIADiasource Immunoassays S.A. SAJME2020-01-09
07340058412077EURIA GlucagonSvar Life Science ABJME2016-08-12