Identity
- Trade Name
- Research and Diagnostic Systems FDA UDI
- Generic Name
- Foeto-maternal haemorrhage/Kleihauer test IVD, kit, fluorescent activated cell sorting/flow cytometry (FACS/Flow) FDA UDI
- Device Name
- FETALtrol 3 x 2 mL (Level 2) FDA UDI
- Model / Reference
- FH1032 FDA UDI
- Description
- FETALtrol 3 x 2 mL (Level 2) FDA UDI
Identifiers
- Catalog Number
- FH1032 FDA UDI
- Primary DI / UDI-DI
- 10815762021746 FDA UDI
- FDA Product Code
- JPK FDA UDI
- GMDN Term
- Foeto-maternal haemorrhage/Kleihauer test IVD, kit, fluorescent activated cell sorting/flow cytometry (FACS/Flow) FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 864.8625 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
No
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
Dimensions & Sizes
- Size
- Total Volume — 6 Milliliter FDA UDI
Research and Diagnostic Systems by Research And Diagnostic Systems, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Foeto-maternal haemorrhage/Kleihauer test IVD, kit, fluorescent activated cell sorting/flow cytometry (FACS/Flow).
- Research and Diagnostic Systems — RESEARCH AND DIAGNOSTIC SYSTEMS, INC. · Class II
- Research and Diagnostic Systems — RESEARCH AND DIAGNOSTIC SYSTEMS, INC. · Class II
- Research and Diagnostic Systems — RESEARCH AND DIAGNOSTIC SYSTEMS, INC. · Class II
- Research and Diagnostic Systems — RESEARCH AND DIAGNOSTIC SYSTEMS, INC. · Class II
- Research and Diagnostic Systems — RESEARCH AND DIAGNOSTIC SYSTEMS, INC. · Class II
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
- Research And Diagnostic Systems, Inc.
Sources (1)
- FDA UDI 4e6c9fbf-9958-4eb4-b5a8-1fc1f3127485 37 fields · synced May 29, 2026