Identity
- Trade Name
- ELDON HOME KIT HKA 2511-1 FDA UDI
- Generic Name
- ABO/Rh multiple blood grouping IVD, kit, agglutination FDA UDI
- Device Name
- For self-testing of ABO and RhD Blood groups. Not for use for screening purposes prior to transfusion. Dry format cards for ABO and/or RhD determination for the grouping of stabilized venous blood, capillary blood or washed red cells. FDA UDI
- Model / Reference
- 504-18v10 FDA UDI504-18v14 FDA UDI504-18v06 FDA UDI504-18v08 FDA UDI
- Description
- For self-testing of ABO and RhD Blood groups. Not for use for screening purposes prior to transfusion. Dry format cards for ABO and/or RhD determination for the grouping of stabilized venous blood, capillary blood or washed red cells. FDA UDI
Identifiers
- Catalog Number
- 504-18 FDA UDI
- Primary DI / UDI-DI
- 05713494001761 FDA UDI05713494002638 FDA UDI05713494000054 FDA UDI05713494000481 FDA UDI
- 510(k) Number
- K790282 FDA UDI
- FDA Product Code
- KSZ FDA UDI
- GMDN Term
- ABO/Rh multiple blood grouping IVD, kit, agglutination FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 864.9175 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDIIn Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Eldon Home Kit Hka 2511-1 by Eldon Biologicals A/S — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K790282 also covers:
- DOCTOR'S KIT DKS RhD-25 — Eldon Biologicals A/S
- DOCTOR´S KIT DKS RhD-25 — Eldon Biologicals A/S
- ELDON BAG 2521-25 25 ELDONCARD 2521 AB0-D — Eldon Biologicals A/S
- ELDON HOME KIT HKA 2511-1 — Eldon Biologicals A/S
- ELDON MILITARY KIT MKA 2521-25 — Eldon Biologicals A/S
- ELDON SCHOOL KIT SK 2511-30 — Eldon Biologicals A/S
- ELDON SCHOOL KIT SKA 2511-30 — Eldon Biologicals A/S
- ELDON SCHOOL KIT SKA 2521-25 — Eldon Biologicals A/S
- ELDONBOX 2511-100 100 ELDONCARD 2511 — Eldon Biologicals A/S
- ELDONBOX 2521-100 100 ELDONCARD 2521 — Eldon Biologicals A/S
- ONE MAN KIT OKA 2511-1 — Eldon Biologicals A/S
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
- Eldon Biologicals A/S
Sources (4)
- FDA UDI f1270f31-a966-40ff-884d-0f30b2a493b8 38 fields · synced Jun 8, 2026
- FDA UDI fcb0d720-4840-4ff5-86c6-0569795cfa1d 37 fields · synced May 24, 2026
- FDA UDI e01016b2-3615-4aa9-b452-4f4753acfc55 38 fields · synced May 24, 2026
- FDA UDI e8754b9c-7575-4633-9d3b-29ac644db83e 38 fields · synced May 26, 2026