Identity
- Trade Name
- Research and Diagnostic Systems FDA UDI
- Generic Name
- Erythropoietin (EPO) IVD, control FDA UDI
- Device Name
- Quantikine IVD Erythropoietin ELISA Kit FDA UDI
- Model / Reference
- DEP00 FDA UDI
- Description
- Quantikine IVD Erythropoietin ELISA Kit FDA UDI
Identifiers
- Catalog Number
- DEP00 FDA UDI
- Primary DI / UDI-DI
- 00815762021640 FDA UDI
- 510(k) Number
- K936016 FDA UDI
- FDA Product Code
- GGT FDA UDI
- GMDN Term
- Erythropoietin (EPO) IVD, control FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 864.7250 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
Yes
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: Erythropoietin (EPO) IVD, control
Research and Diagnostic Systems by Research And Diagnostic Systems, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- 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 7f7d19de-7812-4598-8553-29be4bd39b35 37 fields · synced Jun 6, 2026