FDA UDI
In Commercial Distribution
🇺🇸 United States
FLEX Mono Rb A-Hu Estrogen Receptor a Clone EP1 RTU (Link)
DI: 05700571106907
·
Model: IR084
·
AGILENT TECHNOLOGIES, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- FLEX Mono Rb A-Hu Estrogen Receptor a Clone EP1 RTU (Link)
- Primary DI
- 05700571106907
- Version / Model
- IR084
- Company Name
- AGILENT TECHNOLOGIES, INC.
- Labeler DUNS
- 084963177
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-16
- Public Version
- 7
- Public Version Date
- 2021-07-26
- Public Version Status
- Update
- Public Device Record Key
- 447ce70e-fd24-4ca5-8993-f08a7cd7ae8d
Device Description
FLEX Monoclonal Rabbit Anti-Human Estrogen Receptor a Clone EP1 Ready-to-Use (Link)
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- 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
- 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 |
|---|---|---|---|---|
| MYA | IMMUNOHISTOCHEMISTRY ANTIBODY ASSAY, ESTROGEN RECEPTOR | Hematology | 864.1860 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 57210 | Estrogen (oestrogen)/progesterone receptor IVD, antibody | One or multiple immunoglobulins capable of binding to specific antigenic determinants and intended to be used for the qualitative and/or quantitative detection of estrogen (oestrogen) and/or progesterone receptors in a clinical specimen. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 05700571106907 | GS1 |
Customer Contacts
- Phone
- +1-805-566-6655
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K120663 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | 40-60 Tests |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius