Duns Number:132528295
Device Description: Hemoglobin Variants System Elution Buffer 2
Catalog Number
2500002
Brand Name
Hemoglobin Variants System
Version/Model Number
250-0002
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
K171664
Product Code
GKA
Product Code Name
ABNORMAL HEMOGLOBIN QUANTITATION
Public Device Record Key
62c40989-f315-42e4-9148-16e34dd59e78
Public Version Date
July 02, 2020
Public Version Number
1
DI Record Publish Date
June 24, 2020
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 | 511 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 428 |
| U | Unclassified | 1 |