AccuDiag™
FDA UDIEUDAMEDClass II (US FDA UDI)
Identity
- Trade Name
- AccuDiag™ sTfR - Soluble Transferrin Receptor ELISA EUDAMEDAccuDiag™ FDA UDI
- Generic Name
- Soluble transferrin receptor IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- AccuDiag™ sTfR - Soluble Transferrin Receptor ELISA EUDAMEDAccuDiag™ sTfR - Soluble Transferrin Receptor ELISA Kit A collection of reagents and other associated materials intended to be used for the quantitative measurement of soluble transferrin receptor protein in a clinical specimen, using an enzyme immunoassay (EIA) method. FDA UDI
- Model / Reference
- Anemia ELISA Kit EUDAMED3126-15 EUDAMEDDACD 3126-15 FDA UDI
- Description
- AccuDiag™ sTfR - Soluble Transferrin Receptor ELISA Kit A collection of reagents and other associated materials intended to be used for the quantitative measurement of soluble transferrin receptor protein in a clinical specimen, using an enzyme immunoassay (EIA) method. FDA UDI
Identifiers
- Catalog Number
- 3126-15 FDA UDI
- Primary DI / UDI-DI
- 00894175000473 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00894175000473 EUDAMED
- FDA Product Code
- DDG FDA UDI
- EMDN Code
- W0102070104 SOLUBLE TRANSFERRIN RECEPTOR EUDAMED
- GMDN Term
- Soluble transferrin receptor IVD, kit, enzyme immunoassay (EIA) FDA UDI
Classification
- Device Class
- Class IVD General EUDAMEDClass II FDA UDI
- Regulation Number
- 866.5880 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
Yes
Implantable
No
Contains Latex
No
Human Tissues
No
Animal Tissues
Yes
Microbial Substances
No
Reagent
No
Self Testing
No
Near-Patient Testing
No
Professional Testing
Yes
Companion Diagnostics
No
Surgical Instrument
No
Prescription Use
No
Over-the-Counter
No
Convenience Kit
Yes
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
No
Category: Soluble transferrin receptor IVD, kit, enzyme immunoassay (EIA)
AccuDiag™ by Diagnostic Automation, Inc. — Class II — IVDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Soluble transferrin receptor IVD, kit, enzyme immunoassay (EIA).
- TfR — Ramco Laboratories, Inc. · Class II
Authorization Coverage (2 countries)
Regulatory Authorizations
IVDD
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | IVDD | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Diagnostic Automation, Inc.
Sources (2)
- FDA UDI fa2c0f42-6322-4158-9403-cbff7c8f043a 37 fields · synced Jul 9, 2026
- EUDAMED 60afe5e0-7c25-41b7-9e10-d9e62d0bd010 61 fields · synced Jul 9, 2026