FDA.reportPublic FDA data

Diagnostic BioSystems

Primary DI
00846405001187
Brand
Diagnostic BioSystems
Company
Diagnostic Biosystems, Inc.
Model
Mob553
Device description
MyoD1, Clone 5.8A, 1 ml
Published
2026-06-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
NJTImmunohistochemistry Reagents And Kits

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NJTImmunohistochemistry Reagents And KitsHematology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00846405001187PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00846405001187008464050011878464050011870846405001187

GMDN Terms#

Term, Definition table
TermDefinition
Myo-D1 protein rhabdomyosarcoma marker IVD, antibodyOne or multiple immunoglobulins capable of binding to specific antigenic determinants and intended to be used for the qualitative and/or quantitative detection of Myo-D1 protein as a marker of rhabdomyosarcoma in a clinical specimen.

Regulatory Flags#

DUNS number
926549064
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00846405016808Diagnostic BioSystemsC0062026-07-09
00846405016822Diagnostic BioSystemsC0042026-07-09
00846405016839Diagnostic BioSystemsC0052026-07-09
00846405016846Diagnostic BioSystemsC0022026-07-09
00846405020102Diagnostic BioSystemsC002-NI2026-07-09
00846405020119Diagnostic BioSystemsC004-NI2026-07-09
00846405020126Diagnostic BioSystemsC005-NI2026-07-09
00846405020133Diagnostic BioSystemsC006-NI2026-07-09
00846405000166Diagnostic BioSystemsMob5692026-06-09
00846405000173Diagnostic BioSystemsMob569-052026-06-09
00846405000180Diagnostic BioSystemsMob569-012026-06-09
00846405000678Diagnostic BioSystemsMob0802026-06-09
00846405000685Diagnostic BioSystemsMob080-052026-06-09
00846405000692Diagnostic BioSystemsMob080-012026-06-09
00846405000760Diagnostic BioSystemsMob0592026-06-09
00846405000777Diagnostic BioSystemsMob059-052026-06-09
00846405000784Diagnostic BioSystemsMob059-012026-06-09
00846405000791Diagnostic BioSystemsMob0542026-06-09
00846405000807Diagnostic BioSystemsMob054-052026-06-09
00846405000814Diagnostic BioSystemsMob054-012026-06-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00841683151340Arginase-1 SP156 Rab.CELL MARQUE CORPORATIONNJT2026-09-04
00841683151364CD163 MRQ-26 Mab.CELL MARQUE CORPORATIONNJT2026-09-04
00841683151371Cytokeratin 5 & 6 D5 & 16B4 Mab.CELL MARQUE CORPORATIONNJT2026-09-04
00841683151388Ep-CAM MOC31 Mab.CELL MARQUE CORPORATIONNJT2026-09-04
00841683151395GATA3 L50-823 Mab.CELL MARQUE CORPORATIONNJT2026-09-04
00841683151401Glypican-3 1G12 Mab.CELL MARQUE CORPORATIONNJT2026-09-04
00841683151418Hepatocyte Specific Antigen (Hep-Par 1) OCH1E5 Mab.CELL MARQUE CORPORATIONNJT2026-09-04
00841683151425IgG4 MRQ-44 Mab.CELL MARQUE CORPORATIONNJT2026-09-04
00841683151432Mammaglobin 31A5 Rab.CELL MARQUE CORPORATIONNJT2026-09-04
00841683151449Microphthalmia Transcription Factor (MiTF) C5/D5 Mab.CELL MARQUE CORPORATIONNJT2026-09-04
00841683151463Napsin A MRQ-60 Mab.CELL MARQUE CORPORATIONNJT2026-09-04
00841683151470p120 Catenin MRQ-5 Mab.CELL MARQUE CORPORATIONNJT2026-09-04
00841683151487PAX8 MRQ-50 Mab.CELL MARQUE CORPORATIONNJT2026-09-04
00841683151494PHH3 PolyclonalCELL MARQUE CORPORATIONNJT2026-09-04
00841683151517Podoplanin D2-40 Mab.CELL MARQUE CORPORATIONNJT2026-09-04
00841683151524Renal Cell Carcinoma PN-15 Mab.CELL MARQUE CORPORATIONNJT2026-09-04
00841683151531S100 Protein 4C4.9 Mab.CELL MARQUE CORPORATIONNJT2026-09-04
00841683151548SOX-10 PolyclonalCELL MARQUE CORPORATIONNJT2026-09-04
00841683151555SOX-11 MRQ-58 Mab.CELL MARQUE CORPORATIONNJT2026-09-04
00841683151562SOX-2 SP76 Rab.CELL MARQUE CORPORATIONNJT2026-09-04
00841683151579C4d SP91 Rab.CELL MARQUE CORPORATIONNJT2026-09-04
04065271108967Claudin-4 (EP417) Rabbit Monoclonal AntibodyCELL MARQUE CORPORATIONNJT2026-09-04
00846405016808Diagnostic BioSystemsDiagnostic Biosystems, Inc.NJT2026-07-09
00846405016822Diagnostic BioSystemsDiagnostic Biosystems, Inc.NJT2026-07-09
00846405016839Diagnostic BioSystemsDiagnostic Biosystems, Inc.NJT2026-07-09
00846405016846Diagnostic BioSystemsDiagnostic Biosystems, Inc.NJT2026-07-09
00846405020102Diagnostic BioSystemsDiagnostic Biosystems, Inc.NJT2026-07-09
00846405020119Diagnostic BioSystemsDiagnostic Biosystems, Inc.NJT2026-07-09
00846405020126Diagnostic BioSystemsDiagnostic Biosystems, Inc.NJT2026-07-09
00846405020133Diagnostic BioSystemsDiagnostic Biosystems, Inc.NJT2026-07-09