FDA UDI
In Commercial Distribution
🇺🇸 United States
EPO [Erythropoietin] ELISA [Enzyme-Linked ImmunoSorbent Assay]
DI: 00083059070255
·
Model: 7025
·
BIOMERICA, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- EPO [Erythropoietin] ELISA [Enzyme-Linked ImmunoSorbent Assay]
- Primary DI
- 00083059070255
- Version / Model
- 7025
- Company Name
- BIOMERICA, INC.
- Labeler DUNS
- 067647321
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-07-01
- Public Version
- 1
- Public Version Date
- 2020-07-09
- Public Version Status
- New
- Public Device Record Key
- d3a34143-ec0c-4c3a-bc12-f048acaee12a
Device Description
The Biomerica EPO ELISA is intended for the quantitative determination of Erythropoietin (EPO) in human serum. This assay is intended for in vitro diagnostic use, as an aid in the diagnosis of anemias and polycythemias. With the advent of the administration of recombinant erythropoietin as a biologic therapy to increase red blood cell mass, an erythropoietin assay may be used also to aid in the prediction and monitoring of response to recombinant erythropoietin treatment in persons with anemias.
Device Characteristics
- Single Use
- No
- 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 |
|---|---|---|---|---|
| GGT | Assay, Erythropoietin | Hematology | 864.7250 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 54150 | Erythropoietin (EPO) IVD, reagent | A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the quantitative measurement of erythropoietin (EPO) in a clinical specimen. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00083059070255 | GS1 |
Customer Contacts
- Phone
- +1 949 645 2111
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K992799 | 000 |