FDA.reportPublic FDA data

RNAscope™ ISH Probe SARS-CoV-2

Primary DI
08500427220088
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
Rx
false
OTC
false
Sterile
false
Single use
false

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
08500427220088PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08500427220088085004272200888500427220088

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
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
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
00850042722015RNAscope™ ISH Probe Kappa2014282014282023-05-08
00850042722022RNAscope™ ISH Probe Lambda2014382014382023-05-08
00850042722039RNAscope™ ISH Probe IGLL52014482014482023-05-08
00850042722008RNAscope™ ISH Probe SARS-CoV-22004402004402022-11-10
08500427220156RNAscope™ ISH Probe Kappa2014282014282023-05-08
08500427220224RNAscope™ ISH Probe Lambda2014382014382023-05-08
08500427220392RNAscope™ ISH Probe IGLL52014482014482023-05-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08595715450544CyFlow™ CD200 PE-Cy7EXBIO Praha, a.s.MVU2025-10-01
08719327450949Anti-HbF PUREIQ Products B.V.MVU2023-01-26
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
08436548983413CD38-multi-epitope-FITCCYTOGNOS SLMVU2023-01-17
08436548984946CD45-APC-C750™CYTOGNOS SLMVU2023-01-17
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