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One Man Kit Oka 2511-1

FDA UDI

Class II (US FDA UDI)

by Eldon Biologicals A/S

Identity

Trade Name
ONE MAN KIT OKA 2511-1 FDA UDI
Generic Name
ABO/Rh multiple blood grouping IVD, kit, agglutination FDA UDI
Device Name
For ABO and RhD Blood grouping. Para ABO y RhD agrupación de la sangre. Not for use for screening purposes prior to transfusion No para uso en cribado antes de transfusion Dry format cards for ABO and /or RhD determination for the grouping of stabilized venous blood, capillary blood or washed resuspended red blood cells. For in vitro diagnostic use by professionals. Manual test for detection/confirmation of the presence or absence of antigens A, B and D on human red blood cells from two individuals per ELDONCARD 2521. For blood centers’, field hospitals preliminary blood group determination prior to conventional blood grouping using capillary blood, venous, or washed suspensions or diluted red blood cells. Not to be used for screening purposes prior to transfusion. FDA UDI
Model / Reference
504-37v01 FDA UDI
Description
For ABO and RhD Blood grouping. Para ABO y RhD agrupación de la sangre. Not for use for screening purposes prior to transfusion No para uso en cribado antes de transfusion Dry format cards for ABO and /or RhD determination for the grouping of stabilized venous blood, capillary blood or washed resuspended red blood cells. For in vitro diagnostic use by professionals. Manual test for detection/confirmation of the presence or absence of antigens A, B and D on human red blood cells from two individuals per ELDONCARD 2521. For blood centers’, field hospitals preliminary blood group determination prior to conventional blood grouping using capillary blood, venous, or washed suspensions or diluted red blood cells. Not to be used for screening purposes prior to transfusion. FDA UDI

Identifiers

Catalog Number
504-37 FDA UDI
Primary DI / UDI-DI
05713494002690 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
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: ABO/Rh multiple blood grouping IVD, kit, agglutination

One Man Kit Oka 2511-1 by Eldon Biologicals A/S — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as ABO/Rh multiple blood grouping IVD, kit, agglutination.

Cleared under the same submission

K790282 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Eldon Biologicals A/S

Sources (1)

  • FDA UDI 43cf0679-5074-48cc-bac3-c0ee1f650d76 37 fields · synced May 30, 2026