ONE MAN KIT OKA 2511-1
Basic Information
- Brand Name
- ONE MAN KIT OKA 2511-1
- Primary DI
- 05713494002690
- Version / Model
- 504-37v01
- Catalog Number
- 504-37
- Company Name
- Eldon Biologicals A/S
- Labeler DUNS
- 307910120
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-07-05
- Public Version
- 1
- Public Version Date
- 2024-07-15
- Public Version Status
- New
- Public Device Record Key
- 43cf0679-5074-48cc-bac3-c0ee1f650d76
Device 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.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- Yes
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| KSZ | System, Test, Automated Blood Grouping And Antibody | Hematology | 864.9175 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 45308 | ABO/Rh multiple blood grouping IVD, kit, agglutination | A collection of immunoglobulins capable of binding to specific antigenic determinants and intended to be used together in testing a clinical specimen for a combination of multiple ABO system and Rh group red blood cell antigens, using an agglutination method. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 05713494002690 | GS1 |
Customer Contacts
- Phone
- +4545931111
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K790282 | 000 |
Storage Conditions
- Type
- Handling Environment Temperature
- Temperature Range
- 5 – 37 Degrees Celsius
- Type
- Storage Environment Temperature
- Temperature Range
- 5 – 37 Degrees Celsius