"SARS-CoV-2 (Severe acute respiratory syndrome coronavirus) Negative/Non-Reactive Control SARS-CoV-2 Negative/Non-Reactive Control is intended for use with in vitro assays for determination of Total antibodies to SARS-CoV-2 (Severe acute respiratory syndrome coronavirus). SARS-CoV-2 Negative/Non-Reactive Control is unassayed without target values and is suitable for use on various analysers. SARS-CoV-2 Negative/Non-Reactive Control is useful in determining the precision of testing systems and allows performance monitoring of multiple test systems. SARS-CoV-2 (Severe acute respiratory syndrome coronavirus) Positive/Reactive Control SARS-CoV-2 Positive/Reactive Control is intended for use with in vitro assays for determination of Total antibodies to SARS-CoV-2 (Severe acute respiratory syndrome coronavirus). SARS-CoV-2 Positive/Reactive Control is unassayed without target values and is suitable for use on various analysers. SARS-CoV-2 Negative/Non-Reactive Control is useful in determining the precision of testing systems and allows performance monitoring of multiple test systems."

"SARS
SARS CoV-2 Controls (SARS-CoV-2) - COV10460

Device Description

A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of total antibodies to severe acute respiratory syndrome-associated coronavirus 2 (SARS-CoV-2), the causative agent of COVID-19, in a clinical specimen.

Environmental Conditions

Storage Environment Temperature - Degrees Celsius

8.00
2.00

Device Sizes

No Data Available

Device Sterilization

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Product Codes

Code: JJX

Device Name: Single (Specified) Analyte Controls (Assayed And Unassayed)

Device Class: 1

Physical State: N/A

Definition: N/A

Submission Type ID: 4

Review Panel: CH

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: N/A

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: N/A

Regulation Number: 862.1660

Third Party Flag: N

Medical Specialty: CH

Device Identifiers

Device Id: 05055273216936

Device Type: Primary

DeviceId Issuing Agency: GS1

Contains DI Number: N/A

Package Quantity: N/A

Package Discontinue Date: N/A

Package Status: N/A

Package Type: N/A