Duns Number:229062427
Device Description: The 3-Reagent Homocysteine Assay for SYNCHRON UniCel DxC System is intended for in vitro q The 3-Reagent Homocysteine Assay for SYNCHRON UniCel DxC System is intended for in vitro quantitative determination of total homocysteine in human serum and plasma. The device can assist in the diagnosis and treatment of patients suspected of having hyperhomocysteinemia and homocystinuria.
Catalog Number
FHYB100/B08175
Brand Name
3-Reagent Homocysteine Assay for SYNCHRON UniCel
Version/Model Number
FHYB100/B08175
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"
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For Single-Use
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Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K112790
Product Code
LPS
Product Code Name
Urinary Homocystine (Nonquantitative) Test System
Public Device Record Key
1bde5089-8078-4b71-ac31-a1fd040ef599
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
July 01, 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 | 2 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 6 |