FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Applied Biosystems
DI: 10190302008334
·
Model: 959943B
·
LIFE TECHNOLOGIES CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Applied Biosystems
- Primary DI
- 10190302008334
- Version / Model
- 959943B
- Company Name
- LIFE TECHNOLOGIES CORPORATION
- Labeler DUNS
- 080131636
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-02-02
- Public Version
- 4
- Public Version Date
- 2023-10-18
- Public Version Status
- Update
- Public Device Record Key
- 5aee922e-1574-46f4-b8c6-2c7f80804bb3
- Distribution End Date
- 2018-04-19
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- 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 |
|---|---|---|---|---|
| 57783 | Streptavidin-enzyme conjugate reagent IVD | A streptavidin-enzyme conjugate intended to be used for the qualitative and/or quantitative detection of immune complexes bound to specific cellular markers in a clinical specimen, using an immunohistochemistry assay. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 10190302008334 | GS1 |