Duns Number:590649471
Device Description: The lyophilised Hemoglobin FASC Control kit contains 4 vials of level 1 control which are The lyophilised Hemoglobin FASC Control kit contains 4 vials of level 1 control which are prepared as a stabilized hemolysate from human blood. The controls are designed for use as quality control materials to monitor the accuracy and precision of laboratory testing procedures.
Catalog Number
-
Brand Name
ExtendSURE
Version/Model Number
HB610
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
-
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
JCM
Product Code Name
Control, Hemoglobin, Abnormal
Public Device Record Key
04e3d077-5840-4e57-bde6-4c0fb3d72fa3
Public Version Date
July 24, 2019
Public Version Number
2
DI Record Publish Date
September 20, 2018
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 | 6 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 5 |