Identity
- Trade Name
- Erytra Eflexis FDA UDI
- Generic Name
- Blood group/antibody screening analyser IVD FDA UDI
- Device Name
- Erytra Eflexis® is a fully-automated analyzer designed to automate in vitro immunohematological testing of human blood utilizing DG Gel 8 cards technology, including Blood Grouping, Antigen Typing, Antibody Screening, Antibody Identification, Antibody Titration, Compatibility Tests, and Direct Antiglobulin Tests. As a standalone analyzer or interfaced to the customer’s Laboratory Information System (LIS), Erytra Eflexis® automates test processing functions and data management requirements using DG Gel 8 cards and digital image processing. FDA UDI
- Model / Reference
- 210600 FDA UDI
- Description
- Erytra Eflexis® is a fully-automated analyzer designed to automate in vitro immunohematological testing of human blood utilizing DG Gel 8 cards technology, including Blood Grouping, Antigen Typing, Antibody Screening, Antibody Identification, Antibody Titration, Compatibility Tests, and Direct Antiglobulin Tests. As a standalone analyzer or interfaced to the customer’s Laboratory Information System (LIS), Erytra Eflexis® automates test processing functions and data management requirements using DG Gel 8 cards and digital image processing. FDA UDI
Identifiers
- Catalog Number
- 210600 FDA UDI
- Primary DI / UDI-DI
- 08437014205305 FDA UDI
- FDA Product Code
- KSZ FDA UDI
- GMDN Term
- Blood group/antibody screening analyser IVD FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 864.9175 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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Blood group/antibody screening analyser IVD
Erytra Eflexis by Diagnostic Grifols Sa — Class II — IVDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Blood group/antibody screening analyser IVD.
- PK7300 — Beckman Coulter, Inc. · Class II
- Erytra — DIAGNOSTIC GRIFOLS SA · Class II
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
IVDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | IVDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Diagnostic Grifols Sa
Sources (2)
- FDA UDI 061c40f2-055e-477c-8975-1d6e320c9380 35 fields · synced Jun 18, 2026
- EUDAMED 1 fields · synced Jun 4, 2026