Identity
- Trade Name
- FMH RapidScreen FDA UDI
- Generic Name
- Foeto-maternal haemorrhage/Kleihauer test IVD, reagent FDA UDI
- Device Name
- The FMH RapidScreen kit is intended for use in the detection of D-positive red blood cells in D-negative mothers. FDA UDI
- Model / Reference
- 0007893 FDA UDI
- Description
- The FMH RapidScreen kit is intended for use in the detection of D-positive red blood cells in D-negative mothers. FDA UDI
Identifiers
- Catalog Number
- 0007893 FDA UDI
- Primary DI / UDI-DI
- 10888234000907 FDA UDI
- FDA Product Code
- LIM FDA UDI
- GMDN Term
- Foeto-maternal haemorrhage/Kleihauer test IVD, reagent FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 864.7455 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
Yes
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Foeto-maternal haemorrhage/Kleihauer test IVD, reagent
FMH RapidScreen by Immucor, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Immucor, Inc.
Sources (1)
- FDA UDI a817b957-8d35-4fd8-9d8e-edfe60e506d6 37 fields · synced May 30, 2026