FDA.reportPublic FDA data

RNAscope™ ISH Probe SARS-CoV-2

Primary DI
00850042722008
Brand
RNAscope™ ISH Probe SARS-CoV-2
Company
Advanced Cell Diagnostics, Inc.
Model
200440
Catalog number
200440
Device description
RNAscope™ ISH Probe SARS-CoV-2 is designed to hybridize to the mRNA transcript of the S gene of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).
Published
2022-11-10
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

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
00850042722008PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850042722008008500427220088500427220080850042722008

GMDN Terms#

Term, Definition table
TermDefinition
SARS-CoV-2 nucleic acid IVD, reagentA substance or reactant intended to be used together with other IVDs to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of nucleic acid from severe acute respiratory syndrome-associated coronavirus 2 (SARS-CoV-2) in a clinical specimen.

Storage And Handling#

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

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
(510) 576-8800Info.ACD@bio-techne.com

Regulatory Flags#

DUNS number
607435869
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850042722015RNAscope™ ISH Probe Kappa2014282014282023-05-08
00850042722022RNAscope™ ISH Probe Lambda2014382014382023-05-08
00850042722039RNAscope™ ISH Probe IGLL52014482014482023-05-08
08500427220156RNAscope™ ISH Probe Kappa2014282014282023-05-08
08500427220224RNAscope™ ISH Probe Lambda2014382014382023-05-08
08500427220392RNAscope™ ISH Probe IGLL52014482014482023-05-08
08500427220088RNAscope™ ISH Probe SARS-CoV-22004402004402022-11-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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08719327450956Anti-HbF FITCIQ Products B.V.MVU2023-01-26
08719327450963Anti-HbF R-PEIQ Products B.V.MVU2023-01-26
08719327450970Anti-HbF Dy-410IQ Products B.V.MVU2023-01-26
08719327450987anti-HbS PUREIQ Products B.V.MVU2023-01-26
08719327450994anti-HbS FITCIQ Products B.V.MVU2023-01-26
08719327451014CD163 PURE IQ Products B.V.MVU2023-01-26
08719327451021CD163 FITCIQ Products B.V.MVU2023-01-26
08719327451038CD163 R-PEIQ Products B.V.MVU2023-01-26
08719327451045CD163 BiotinIQ Products B.V.MVU2023-01-26
08719327451052CD64 PUREIQ Products B.V.MVU2023-01-26
08719327451069CD64 CyQIQ Products B.V.MVU2023-01-26
08719327451076CD64 FITCIQ Products B.V.MVU2023-01-26
08719327451083CD64 R-PEIQ Products B.V.MVU2023-01-26
08719327451090CD64 R-PEIQ Products B.V.MVU2023-01-26
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08436548984946CD45-APC-C750™CYTOGNOS SLMVU2023-01-17
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