FDA UDI
Not in Commercial Distribution
🇺🇸 United States
FLEX Mono Mo A-Hu CD99, MIC2 Gene Product Ewing’s Sarcoma Marker Cl 12E7 RTU
DI: 05700571101858
·
Model: IS057
·
AGILENT TECHNOLOGIES, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- FLEX Mono Mo A-Hu CD99, MIC2 Gene Product Ewing’s Sarcoma Marker Cl 12E7 RTU
- Primary DI
- 05700571101858
- Version / Model
- IS057
- Company Name
- AGILENT TECHNOLOGIES, INC.
- Labeler DUNS
- 084963177
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-09-17
- Public Version
- 3
- Public Version Date
- 2023-09-04
- Public Version Status
- Update
- Public Device Record Key
- 20092e47-8c09-4334-8050-fc61f6abd8b3
- Distribution End Date
- 2022-08-31
Device Description
FLEX Monoclonal Mouse Anti-Human CD99, MIC2 Gene Product Ewing’s Sarcoma Marker Clone 12E7 Ready-to-Use (Dako Autostainer/ Autostainer Plus)
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
- Yes
- 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 |
|---|---|---|---|---|
| NJT | IMMUNOHISTOCHEMISTRY REAGENTS AND KITS | Hematology | 864.1860 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 57028 | CD99 cell marker 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 CD99 cell marker in a clinical specimen. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 05700571101858 | GS1 |
Customer Contacts
- Phone
- +1-800-227-9770
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | 20-30 Tests |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius