Duns Number:045623154
Device Description: Pointe Scientific, Inc. Toxoplasma IgG Reagent is for the qualitative, semi-quantitative o Pointe Scientific, Inc. Toxoplasma IgG Reagent is for the qualitative, semi-quantitative or quantitative detection of human IgG antibodies to Toxoplasma gondii in human serum by enzyme immunoassay, as an aid in the determination of infection with Toxoplasma. When used as a qualitative test, Toxoplasma IgG EIA aids in the assessment of the patient's immunological response to toxoplasma. These reagents have not received FDA clearance for use in testing blood or plasma donors. 96 tests
Catalog Number
T81001-96
Brand Name
Pointe Scientific, Inc. Toxoplasma IgG
Version/Model Number
T8001-96
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
K960092
Product Code
LGD
Product Code Name
Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii
Public Device Record Key
fdd3a1d1-a14a-4de1-bdf0-cb2a080d7bd8
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
August 31, 2016
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 |