FDA UDI
Not in Commercial Distribution
🇺🇸 United States
ELDON SCHOOL KIT SKA 2521-25
DI: 05713494000405
·
Model: 614-08v02
·
Eldon Biologicals A/S
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
50
Basic Information
- Brand Name
- ELDON SCHOOL KIT SKA 2521-25
- Primary DI
- 05713494000405
- Version / Model
- 614-08v02
- Catalog Number
- 614-08
- Company Name
- Eldon Biologicals A/S
- Labeler DUNS
- 307910120
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 50
- Record Status
- Published
- Publish Date
- 2017-05-15
- Public Version
- 5
- Public Version Date
- 2022-12-05
- Public Version Status
- Update
- Public Device Record Key
- b81fed29-7b13-4313-9d0a-28a829e028cc
- Distribution End Date
- 2018-07-06
Device 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.
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 | 05713494000405 | GS1 | ||||
| Unit of Use | 05713494000313 | GS1 |
Customer Contacts
- Phone
- +4545931111
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K790282 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 5 – 37 Degrees Celsius
- Type
- Handling Environment Temperature
- Temperature Range
- 5 – 37 Degrees Celsius