Duns Number:878252071
Device Description: AccuDiag ™ Strongyloides IgG ELISAThe Strongyloides ELISA test is a qualitative enzyme imm AccuDiag ™ Strongyloides IgG ELISAThe Strongyloides ELISA test is a qualitative enzyme immunoassay for the detection of antibodies to Strongyloides, in samples of human serum or plasma.
Catalog Number
8319-35
Brand Name
AccuDiag ™
Version/Model Number
DACD 8319-35
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
Yes
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
MDT
Product Code Name
Elisa, Trichinella Spiralis
Public Device Record Key
1644e4d0-98ad-4b8b-b70e-1ddb147d4197
Public Version Date
August 31, 2021
Public Version Number
1
DI Record Publish Date
August 23, 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 | 7 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 16 |