Duns Number:227530649
Device Description: ToRCH EBV Positive Control is intended for use with in vitro assays for determination of I ToRCH EBV Positive Control is intended for use with in vitro assays for determination of IgG and IgM antibodies to the viral capsid antigen of Epstein-Barr Virus (EBV VCA) and IgG antibodies to the viral polypeptide nuclear antigen of Epstein-Barr Virus (EBV EBNA).ToRCH EBV Positive Control is unassayed without target values and is suitable for use on many analysers. This control must not be used as a substitute for the mandatory manufacturer’s kit controls provided with the assay.ToRCH EBV Positive Control is helpful in determining the precision of testing systems and in identifying sources of variation.
Catalog Number
SR10350
Brand Name
SEROLOGY ToRCH EBV POSITIVE CONTROL (ToRCH EBV CONTROL +)
Version/Model Number
SR10350
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
OHQ
Product Code Name
Multi-Analyte Controls Unassayed
Public Device Record Key
009ca915-5f13-4a74-a7ab-bb56a81b41fc
Public Version Date
December 21, 2020
Public Version Number
2
DI Record Publish Date
March 04, 2020
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 305 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 258 |