RNAscope™ ISH Probe SARS-CoV-2

Basic Information

• Brand Name: RNAscope™ ISH Probe SARS-CoV-2
• Primary DI: 00850042722008
• Version / Model: 200440
• Catalog Number: 200440
• Company Name: Advanced Cell Diagnostics, Inc.
• Labeler DUNS: 607435869
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-11-10
• Public Version: 4
• Public Version Date: 2023-11-07
• Public Version Status: Update
• Public Device Record Key: c3ed4752-9019-499f-be75-049630f26b3f

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).

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
MVU	Reagents, Specific, Analyte	Pathology	864.4020	1

GMDN Terms

Code	Name	Definition	Implantable	Status
66213	SARS-CoV-2 nucleic acid IVD, reagent	A 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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00850042722008	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 2 – 8 Degrees Celsius