Identity
- Trade Name
- R&D CBC-DH Hematology Control FDA UDI
- Generic Name
- Full blood count IVD, control FDA UDI
- Device Name
- 12 x 3 mL; 4 each level low, normal, high FDA UDI
- Model / Reference
- DH004 FDA UDI
- Description
- 12 x 3 mL; 4 each level low, normal, high FDA UDI
Identifiers
- Catalog Number
- DH004 FDA UDI
- Primary DI / UDI-DI
- 00815762026348 FDA UDI
- GMDN Term
- Full blood count IVD, control FDA UDI
Classification
- Commercial Distribution
- Not 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
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
R&D CBC-DH Hematology Control by Research And Diagnostic Systems, Inc. — 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 | N/A | Pending data |
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Manufacturer
- Manufacturer
- Research And Diagnostic Systems, Inc.
Sources (1)
- FDA UDI 16f58c0a-97f1-465c-8e61-b51272243d22 35 fields · synced May 30, 2026