Duns Number:072915986
Device Description: A two-level hematology control used to monitor erythrocyte sedimentation rates. Contains A two-level hematology control used to monitor erythrocyte sedimentation rates. Contains 6 vials each of level 1 & 2.
Catalog Number
240408
Brand Name
ESR-Chex Plus
Version/Model Number
240408
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
JPH
Product Code Name
Test, Erythrocyte Sedimentation Rate
Public Device Record Key
1ac99ff9-e555-46da-a21a-01bb1777be2a
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
September 19, 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 | 30 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 136 |