FDA.reportPublic FDA data

Augurex

Primary DI
00628425360013
Brand
Augurex
Company
Augurex Life Sciences Corp
Model
1.0
Catalog number
90-0000420
Device description
14-3-3eta SRM POS M, 10-pack, ASR
Published
2024-10-23
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
MVUReagents, Specific, Analyte

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MVUReagents, Specific, AnalytePathology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00628425360013PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00628425360013006284253600136284253600130628425360013

GMDN Terms#

Term, Definition table
TermDefinition
Protein 14-3-3 IVD, reagentA substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of protein 14-3-3 in a clinical specimen.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
252066324
Device count
1
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00628425360044Augurex1.090-00052026-04-20
00628425360075Auguerx1.090-00132026-04-20
00628425360082Augurex1.090-00152026-04-20
00628425360099Augurex1.090-00162026-04-20
00628425360105Augurex1.090-00202026-04-20
00628425360112Augurex1.090-00312026-04-20
00628425360129Augurex1.090-00382026-04-20
00628425360006Augurex1.090-00004182024-10-23
00628425360020Augurex1.090-00004212024-10-23
00628425360037Augurex1.090-00004192024-10-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810034704399FITC anti-human Ki-67BIOLEGEND, INC.MVU2026-09-04
00810034704481PE anti-human CD366BIOLEGEND, INC.MVU2026-09-04
00810034703170PerCP anti-human CD61BIOLEGEND, INC.MVU2026-08-07
03661540953170DSQ Alert HT Adenovirus Primer Mix ASRElitechgroup Mdx LLCMVU2026-08-07
03661540953187DSQ Alert HT Adenovirus Probe Mix ASRElitechgroup Mdx LLCMVU2026-08-07
03661540953217DSQ Alert Hepatitis E Primer Mix ASRElitechgroup Mdx LLCMVU2026-08-07
03661540953224DSQ Alert Hepatitis E Probe Mix ASRElitechgroup Mdx LLCMVU2026-08-07
03661540953279DSQ Alert Mycoplasma pneumoniae Primer Mix ASRElitechgroup Mdx LLCMVU2026-08-07
03661540953286DSQ Alert Mycoplasma pneumoniae Probe Mix ASRElitechgroup Mdx LLCMVU2026-08-07
00810034704252FITC anti-human TNF-AlphaBIOLEGEND, INC.MVU2026-07-28
00810034704320PE anti-human IL-2BIOLEGEND, INC.MVU2026-07-28
00810227730211Fort Worth DiagnosticsFort Worth Diagnostics, LLCMVU2026-07-24
00850051429820Fort Worth DiagnosticsFort Worth Diagnostics, LLCMVU2026-07-24
00850051429837Fort Worth DiagnosticsFort Worth Diagnostics, LLCMVU2026-07-24
00850051429844Fort Worth DiagnosticsFort Worth Diagnostics, LLCMVU2026-07-24
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00810227730006Fort Worth DiagnosticsFort Worth Diagnostics, LLCMVU2026-07-22
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00810227730020Fort Worth DiagnosticsFort Worth Diagnostics, LLCMVU2026-07-22
00810227730037Fort Worth DiagnosticsFort Worth Diagnostics, LLCMVU2026-07-22
00850051429967Fort Worth DiagnosticsFort Worth Diagnostics, LLCMVU2026-07-22
00850051429974Fort Worth DiagnosticsFort Worth Diagnostics, LLCMVU2026-07-22
00850051429981Fort Worth DiagnosticsFort Worth Diagnostics, LLCMVU2026-07-22
00850051429998Fort Worth DiagnosticsFort Worth Diagnostics, LLCMVU2026-07-22
00810227730044Fort Worth DiagnosticsFort Worth Diagnostics, LLCMVU2026-07-21
00810227730051Fort Worth DiagnosticsFort Worth Diagnostics, LLCMVU2026-07-21
00810227730068Fort Worth DiagnosticsFort Worth Diagnostics, LLCMVU2026-07-21
00810227730136Fort Worth DiagnosticsFort Worth Diagnostics, LLCMVU2026-07-21
00810227730143Fort Worth DiagnosticsFort Worth Diagnostics, LLCMVU2026-07-21
00810227730150Fort Worth DiagnosticsFort Worth Diagnostics, LLCMVU2026-07-21