Duns Number:045623154
Device Description: Pointe Opiates 300 Reagent Set 1 x 1000 mL R1, 1 x 375 mL R2 The Pointe Opiates 300 Reagen Pointe Opiates 300 Reagent Set 1 x 1000 mL R1, 1 x 375 mL R2 The Pointe Opiates 300 Reagent Set is intended for the qualitative and semi-quantitative determination of opiates in human urine at a cutoff value of 300 ng/mL when calibrated against morphine. The assay is designed for prescription use with a number of automated clinical chemistry analyzers. This assay is for prescription use only.
Catalog Number
60-OP0040-1L
Brand Name
Pointe Opiates 300 Reagent Set
Version/Model Number
60-OP0040-1L
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
K110298
Product Code
DJG
Product Code Name
Enzyme Immunoassay, Opiates
Public Device Record Key
27df7560-3146-4682-bb98-42886a4ea9f9
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 |