FDA UDI
In Commercial Distribution
🇺🇸 United States
Dako
DI: 05700575002427
·
Model: IF001
·
AGILENT TECHNOLOGIES SINGAPORE PTE LTD
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Dako
- Primary DI
- 05700575002427
- Version / Model
- IF001
- Company Name
- AGILENT TECHNOLOGIES SINGAPORE PTE LTD
- Labeler DUNS
- 894671143
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-06-18
- Public Version
- 1
- Public Version Date
- 2024-06-26
- Public Version Status
- New
- Public Device Record Key
- 515e6b3f-eb49-427e-ac95-59d8a37e04a1
Device Description
Monoclonal Mouse Anti-Human Terminal Deoxynucleotidyl Transferase / iFlour 488 Clone DAK-TDT
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 |
|---|---|---|---|---|
| MVU | Reagents, specific, analyte | Pathology | 864.4020 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 57644 | Terminal deoxynucleotidyl transferase (TdT) 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 terminal deoxynucleotidyl transferase (TdT) in a clinical specimen. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 05700575002427 | GS1 |
Customer Contacts
- Phone
- +1-800-227-9770
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Total Volume | 0.5 | Milliliter |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep away from sunlight
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius