Duns Number:008254708
Device Description: The Access Prolactin assay is a paramagnetic particle, chemiluminescent immunoassay for th The Access Prolactin assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of prolactin (PRL) levels in human serum and plasma (heparin) using the Access Immunoassay Systems.
Catalog Number
33530
Brand Name
ACCESS PROLACTIN
Version/Model Number
33530
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
-
Product Code
CFT
Product Code Name
Radioimmunoassay, Prolactin (Lactogen)
Public Device Record Key
d511233a-4103-4172-ada7-07507e12b86c
Public Version Date
September 13, 2021
Public Version Number
1
DI Record Publish Date
September 03, 2021
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 | 319 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 503 |
| 3 | A medical device with high risk that requires premarket approval | 9 |
| U | Unclassified | 1 |