FDA.reportPublic FDA data

HPV E6, E7 mRNA Probe, Ready to Use

Primary DI
B766C313150
Brand
HPV E6, E7 mRNA Probe, Ready to Use
Company
INCELLDX, INC.
Model
C31315
Device description
HPV E6, E7 mRNA Probe, Ready to Use is specific for Human Papillomavirus types 16 and 18 E6,E7 mRNA. HPV E6,E7 genes are transcribed as a single transcript using a common promoter and early polyadenylation site. HPV E6, E7 mRNA Probe, Ready to Use is comprised of a cocktail of 85% pure full-length dual fluorescein-labelled molecules as verified by Reverse Phase HPLC.
Published
2023-02-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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
B766C313150PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Nucleic acid hybridization detection IVD, probeA defined piece(s) of nucleic acid, typically tagged with a fluorescent marker, intended to be used for the detection of a specific target nucleotide sequence at a single-gene locus or whole/partial chromosome level in a clinical specimen, in order to identify chromosomal abnormalities (e.g., aneuploidy, deletion, translocation, duplication, inversion, gene insertion). It is typically used in nucleic acid hybridization detection techniques [e.g., fluorescent in situ hybridization (FISH), chromogenic ISH (CISH)].

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
833074623
Device count
1
DM exempt
true
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B766C310500Anti PD-L1 AntibodyC31050C310502020-02-05
B766U310750Anti CD45 AntibodyU31075U310752020-02-05
B766U311000Anti Pan Cytokeratin AntibodyU31100U311002020-02-05
B766C311000HPV E6, E7 mRNA Probe C31100C311002019-09-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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00810034704177FITC anti-human CD69BIOLEGEND, INC.MVU2026-06-05
00810034704191PE/Cyanine7 anti-human CD69BIOLEGEND, INC.MVU2026-06-05
00810034704214APC anti-human CD31BIOLEGEND, INC.MVU2026-06-05
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00810034704108PE/Cyanine7 anti-human CD22BIOLEGEND, INC.MVU2026-06-01
00810034704139PE/Cyanine7 anti-human CD300eBIOLEGEND, INC.MVU2026-06-01
08595715450544CyFlow™ CD200 PE-Cy7EXBIO Praha, a.s.MVU2025-10-01
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08719327450970Anti-HbF Dy-410IQ Products B.V.MVU2023-01-26
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08719327451052CD64 PUREIQ Products B.V.MVU2023-01-26
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08719327451076CD64 FITCIQ Products B.V.MVU2023-01-26
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