| Primary Device ID | 05713494000085 |
| NIH Device Record Key | 9bf073e0-94cf-4cd6-a38c-7c5a19240c40 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | DOCTOR´S KIT DKS RhD-25 |
| Version Model Number | 660-01v05 |
| Catalog Number | 660-01 |
| Company DUNS | 307910120 |
| Company Name | Eldon Biologicals A/S |
| Device Count | 75 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | true |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Phone | +4545931111 |
| eldoncard@eldoncard.com |
| Storage Environment Temperature | Between 5 Degrees Celsius and 37 Degrees Celsius |
| Handling Environment Temperature | Between 5 Degrees Celsius and 37 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 05713494000085 [Primary] |
| GS1 | 05713494000320 [Unit of Use] |
| KSZ | System, Test, Automated Blood Grouping And Antibody |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2016-09-07 |
| 05713494002690 - ONE MAN KIT OKA 2511-1 | 2024-07-15 For ABO and RhD Blood grouping. Para ABO y RhD agrupación de la sangre. Not for use for screening purposes prior to transfusion |
| 05713494002638 - ELDON HOME KIT HKA 2511-1 | 2023-03-16 For self-testing of ABO and RhD Blood groups. Not for use for screening purposes prior to transfusion. Dry format cards for ABO |
| 05713494002409 - ELDON HOME KIT HKA 2511-1 | 2022-12-06 For self-testing of ABO and RhD Blood groups. Not for use for screening purposes prior to transfusion. Dry format cards for ABO |
| 05713494001761 - ELDON HOME KIT HKA 2511-1 | 2021-10-19 For self-testing of ABO and RhD Blood groups. Not for use for screening purposes prior to transfusion. Dry format cards for ABO |
| 05713494001778 - ELDON HOME KIT HKA 2511-1 | 2021-10-19 For self-testing of ABO and RhD Blood groups. Not for use for screening purposes prior to transfusion. Dry format cards for ABO |
| 05713494002270 - ELDON HOME KIT HKA 2511-1 | 2021-09-24 For self-testing of ABO and RhD Blood groups. Not for use for screening purposes prior to transfusion. Dry format cards for ABO |
| 05713494001990 - ELDON HOME KIT HKA 2511-1 | 2021-05-05 For self-testing of ABO and RhD Blood groups. Not for use for screening purposes prior to transfusion. Dry format cards for ABO |
| 05713494000313 - ELDONBOX 2521-100 100 ELDONCARD 2521 | 2021-02-12 For ABO and Rh D blood grouping Para ABO y Rh D agrupación de la sangre. Not for use for screening purposes prior to transfusio |