Duns Number:045623154
Device Description: Pointe Scientific, Inc. CMV IgM Reagent is for the qualitative detection of human IgM anti Pointe Scientific, Inc. CMV IgM Reagent is for the qualitative detection of human IgM antibodies to cytomegalovirus (CMV) in human serum by enzyme immunoassay, to aid in the diagnosis of CMV infection. A positive result is presumptive for the detection of anti-CMV IgM antibodies and presumptive for the diagnosis of acute or recent CMV infection. These reagents have not received FDA clearance for use in testing blood or plasma donors. 96 tests.
Catalog Number
T8006-96
Brand Name
Pointe Scientific, Inc. CMV IgM
Version/Model Number
T8006-96
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
K982485
Product Code
LFZ
Product Code Name
Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus
Public Device Record Key
478fbfad-9cad-4f9d-a451-a943dee756a2
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 |