FDA.reportPublic FDA data

SeptiCyte RAPID [US IVD]

Primary DI
00860007612657
Brand
SeptiCyte RAPID [US IVD]
Company
Immunexpress Inc.
Model
SA3020U
Device description
Sepsis Host Response US IVD EDTA PAXgene Variant Cartridge
Published
2024-03-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
PRERt-Qpcr Assay For Mrna Transcript Immune Biomarkers

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PRERt-Qpcr Assay For Mrna Transcript Immune BiomarkersMicrobiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860007612657PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860007612657008600076126578600076126570860007612657

GMDN Terms#

Term, Definition table
TermDefinition
Reverse transcription reagent kit IVDA collection of reagents and other associated materials intended to be used in the synthesis of complimentary deoxyribonucleic acid (cDNA) by reverse transcription, to facilitate the amplification of target ribonucleic acid (RNA) in a clinical specimen, using a polymerase chain reaction (PCR) technique.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
964789676
Device count
1
Kit
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10860007612654SeptiCyte RAPID [US IVD]SB3020U2024-03-17
10860007612616SeptiCyte RAPIDSB3010U2022-12-20
00860007612619SeptiCyte RAPIDSA3010U2022-12-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10860007612654SeptiCyte RAPID [US IVD]Immunexpress Inc.PRE2024-03-17
10860007612616SeptiCyte RAPIDImmunexpress Inc.PRE2022-12-20
00860007612619SeptiCyte RAPIDImmunexpress Inc.PRE2022-12-10