FDA UDI
In Commercial Distribution
🇺🇸 United States
Erytra Eflexis
DI: 08437014205305
·
Model: 210600
·
DIAGNOSTIC GRIFOLS SA
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Erytra Eflexis
- Primary DI
- 08437014205305
- Version / Model
- 210600
- Catalog Number
- 210600
- Company Name
- DIAGNOSTIC GRIFOLS SA
- Labeler DUNS
- 463625602
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-03-21
- Public Version
- 4
- Public Version Date
- 2025-04-29
- Public Version Status
- Update
- Public Device Record Key
- 061c40f2-055e-477c-8975-1d6e320c9380
Device Description
Erytra Eflexis® is a fully-automated analyzer designed to automate in vitro immunohematological testing of human blood utilizing DG Gel 8 cards technology, including Blood Grouping, Antigen Typing, Antibody Screening, Antibody Identification, Antibody Titration, Compatibility Tests, and Direct Antiglobulin Tests. As a standalone analyzer or interfaced to the customer’s Laboratory Information System (LIS), Erytra Eflexis® automates test processing functions and data management requirements using DG Gel 8 cards and digital image processing.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- 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
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- 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 |
|---|---|---|---|---|
| 56714 | Blood group/antibody screening analyser IVD | An electrically-powered automated or semi-automated laboratory instrument intended to be used to perform pre-transfusion blood group testing, red cell antibody screening/identification and/or red cell phenotyping of clinical specimens or donor specimens in order to determine suitability for transfusion or transplantation. Testing may include ABO, Rhesus or other red cell blood group systems and may use microplate-based serological methods, cassettes or column agglutinating technology. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08437014205305 | GS1 |
Customer Contacts
- Phone
- (800)452-6877
- [email protected]