Duns Number:045623154
Device Description: Acid Phosphatase Reagent Set used for the quantitative determination of acid phosphatase i Acid Phosphatase Reagent Set used for the quantitative determination of acid phosphatase in serum.10x10ml Reagent.
Catalog Number
A7503-100
Brand Name
Pointe Scientific, Inc.
Version/Model Number
A7503-100
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K863832
Product Code
JFH
Product Code Name
Acid Phosphatase (Prostatic), Tartrate Inhibited
Public Device Record Key
d5c9ac9e-eb5d-46ad-9a87-8e191a81bbac
Public Version Date
July 23, 2018
Public Version Number
4
DI Record Publish Date
August 31, 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 | 217 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 455 |
| U | Unclassified | 2 |