Duns Number:045623154
Device Description: Pointe Amphetamines 500 Reagent Set 1 x 100 mL R1, 1 x 37.5 mL R2 The Pointe Amphetamines Pointe Amphetamines 500 Reagent Set 1 x 100 mL R1, 1 x 37.5 mL R2 The Pointe Amphetamines 500 Reagent Set is intended for the qualitative and semi-quantitative determination of methamphetamine and amphetamine in human urine at a cutoff value of 500 ng/mL when calibrated with d-methamphetamine. The assay is designed for prescription use with a number of automated clinical chemistry analyzers.
Catalog Number
60-AM0200-100
Brand Name
Pointe Amphetamines 500 Reagent Set
Version/Model Number
60-AM0200-100
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
K102210
Product Code
DKZ
Product Code Name
Enzyme Immunoassay, Amphetamine
Public Device Record Key
0db2b28e-a9ee-41c3-9811-e4e082086745
Public Version Date
October 05, 2020
Public Version Number
1
DI Record Publish Date
September 25, 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 | 217 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 455 |
| U | Unclassified | 2 |