Duns Number:227530649
Device Description: The Human Assayed Multi-sera is supplied at 2 levels, level 2 and 3. Target values and ran The Human Assayed Multi-sera is supplied at 2 levels, level 2 and 3. Target values and ranges are supplied for the analytes listed in the values section at both levels.
Catalog Number
-
Brand Name
HUMAN ASSAYED MULTI-SERA/ASSAYED CHEMISTRY PREMIUM PLUS - LEVEL 2 (HUM ASY CONTR
Version/Model Number
HN1530
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
JJY
Product Code Name
Multi-Analyte Controls, All Kinds (Assayed)
Public Device Record Key
07ea9c81-266c-465c-94c2-28a57324c3b6
Public Version Date
October 12, 2022
Public Version Number
1
DI Record Publish Date
October 04, 2022
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 |