FDA UDI
In Commercial Distribution
🇺🇸 United States
Erythropoietin ELISA
DI: B24221EPOHUE010
·
Model: 21-EPOHU-E01
·
AMERICAN LABORATORY PRODUCTS COMPANY, LTD.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Erythropoietin ELISA
- Primary DI
- B24221EPOHUE010
- Version / Model
- 21-EPOHU-E01
- Catalog Number
- 21-EPOHU-E01
- Company Name
- AMERICAN LABORATORY PRODUCTS COMPANY, LTD.
- Labeler DUNS
- 784143778
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-08-03
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- 99201864-0ee6-43bc-8793-db555beaeefe
Device Description
The EPO ELISA is intended for use in 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.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- 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 |
|---|---|---|---|---|
| 54149 | Erythropoietin (EPO) IVD, kit, chemiluminescent immunoassay | A collection of reagents and other associated materials intended to be used for the quantitative measurement of erythropoietin (EPO) in a clinical specimen, using a chemiluminescent immunoassay method. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | B24221EPOHUE010 | HIBCC |
Customer Contacts
- Phone
- 800.592.5726
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K992799 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius