Duns Number:061446282
Device Description: The FMH RapidScreen kit is intended for use in the detection of D-positive red blood cells The FMH RapidScreen kit is intended for use in the detection of D-positive red blood cells in D-negative mothers.
Catalog Number
0007893
Brand Name
FMH RapidScreen
Version/Model Number
0007893
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)
Yes
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
BK110067
Product Code
LIM
Product Code Name
Test, Screening, For D Positive Fetal Rbc'S
Public Device Record Key
a817b957-8d35-4fd8-9d8e-edfe60e506d6
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
April 14, 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 | 18 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 58 |
| U | Unclassified | 3 |