Identity
- Trade Name
- DOCTOR'S KIT DKS RhD-25 FDA UDI
- Generic Name
- Anti-Rh(D) red blood cell grouping IVD, antibody FDA UDI
- Device Name
- For 75 RhD blood group determinations. Not for use for screening purposes prior to transfusion. Dry format cards for RhD determination for the grouping of stabilized venous blood, capillary blood or washed red cells. FDA UDI
- Model / Reference
- 669-00v07 FDA UDI
- Description
- For 75 RhD blood group determinations. Not for use for screening purposes prior to transfusion. Dry format cards for RhD determination for the grouping of stabilized venous blood, capillary blood or washed red cells. FDA UDI
Identifiers
- Catalog Number
- 669-00 FDA UDI
- Primary DI / UDI-DI
- 05713494000351 FDA UDI
- 510(k) Number
- K790282 FDA UDI
- FDA Product Code
- KSZ FDA UDI
- GMDN Term
- Anti-Rh(D) red blood cell grouping IVD, antibody 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
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
Category: Anti-Rh(D) red blood cell grouping IVD, antibody
DOCTOR'S KIT DKS RhD-25 by Eldon Biologicals A/S — Class II — IVDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Anti-Rh(D) red blood cell grouping IVD, antibody.
- Beckman Coulter® PK® Systems Anti-D (PK1) (P3X61) — DIAGAST
- Anti-D (Monoclonal Blend) Series 5 — IMMUCOR, INC.
- ORTHO — Ortho-Clinical Diagnostics
- Anti-D (RH1) IgM+IgG — DIAGAST
- Anti-D (RH1) IgM — DIAGAST
- Anti-D (Monoclonal Blend) Gamma-clone — IMMUCOR, INC.
- IH-Anti D (RH1) Blend — Bio-Rad Medical Diagnostics GmbH
- IH-Card Anti-D (DVI-) — Bio-Rad Medical Diagnostics GmbH
Cleared under the same submission
K790282 also covers:
- 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 (2 countries)
Regulatory Authorizations
European Union Unknown
IVDD
United States Pending data
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
- Eldon Biologicals A/S
Sources (2)
- FDA UDI 62a6323b-d9c0-4dc4-8585-baee4dae103d 37 fields · synced Jun 18, 2026
- EUDAMED 1 fields · synced Jun 4, 2026