Duns Number:388240673
Device Description: Quantitative determination of homocysteine in human serum and plasma on BN II and BN ProSp Quantitative determination of homocysteine in human serum and plasma on BN II and BN ProSpec® Systems
Catalog Number
OPAX03
Brand Name
N Latex HCY
Version/Model Number
10445973
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
-
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K052788
Product Code
LPS
Product Code Name
URINARY HOMOCYSTINE (NONQUANTITATIVE) TEST SYSTEM
Public Device Record Key
b7f2fe99-6b93-4478-8b71-61e5279395a7
Public Version Date
November 18, 2021
Public Version Number
5
DI Record Publish Date
September 24, 2016
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 | 25 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 101 |