Duns Number:227530649
Device Description: Serology II Positive Control is intended for use with in vitro assays for determination of Serology II Positive Control is intended for use with in vitro assays for determination of antibodies to Hepatitis B Surface Antigen (Anti HBs), IgG antibodies to Hepatitis B Core Antibodies (Anti HBc), antibodies to Hepatitis A (Anti HAV) and antibodies to Hepatitis B Envelope (Anti HBe). Serology II Positive Control is unassayed without target values and is suitable for use on many analysers. These controls must not be used as a substitute for the mandatory manufacturer’s kit controls provided with the assay.Serology II Positive Control is helpful in determining the precision of testing systems and in identifying sources of variation.
Catalog Number
SR10353
Brand Name
SEROLOGY II POSITIVE CONTROL (SEROLOGY II CONTROL +)
Version/Model Number
SR10353
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
ea55ed63-18c5-47ee-821a-5893e36fe959
Public Version Date
December 21, 2020
Public Version Number
2
DI Record Publish Date
May 11, 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 |