Duns Number:689062203
Device Description: AFIAS-6/SP Analyzer is a flurorescence-scanning for in vitro diagnostic use at clinical la AFIAS-6/SP Analyzer is a flurorescence-scanning for in vitro diagnostic use at clinical laboratories and Point-Of-Care(POC) sites in conjunction with various in vitro diagnostic AFIAS immunoassats for measuring the concentration of designated analytes in serum or plasma samples.
Catalog Number
FPRR020-4
Brand Name
AFIAS-6/SP Analyzer
Version/Model Number
FPRR020-4
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
K170232
Product Code
JLW
Product Code Name
Radioimmunoassay, Thyroid-Stimulating Hormone
Public Device Record Key
bdf0f8da-ef9c-4a00-b6c6-beed72f0d357
Public Version Date
December 13, 2019
Public Version Number
4
DI Record Publish Date
November 06, 2017
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 | 5 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 2 |