FDA UDI
In Commercial Distribution
🇺🇸 United States
C10PW-SI
DI: 05700574034641
·
Model: C10PW-SI
·
AGILENT TECHNOLOGIES, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- C10PW-SI
- Primary DI
- 05700574034641
- Version / Model
- C10PW-SI
- Company Name
- AGILENT TECHNOLOGIES, INC.
- Labeler DUNS
- 084963177
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-06-01
- Public Version
- 1
- Public Version Date
- 2022-06-09
- Public Version Status
- New
- Public Device Record Key
- 324ba112-cc1a-4405-b168-c84a5175a894
Device Description
Cell Imaging Multi-Mode Reader
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
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| JJQ | COLORIMETER, PHOTOMETER, SPECTROPHOTOMETER FOR CLINICAL USE | Clinical Chemistry | 862.2300 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 62338 | Cell-imaging microplate reader IVD | A mains electricity (AC-powered) laboratory instrument intended to be used for live cell imaging and observation of cell-based assays in microplates, and for the optical detection of analytes in a clinical specimen. The device it typically a single unit consisting of a digital microscope and a multi-modality (i.e., fluorescence, chemiluminescence, absorbance) optical reader. It may also be temperature and gas controlled (i.e., CO2 and O2) for incubation of microplates. The device operates with minimal technician involvement and complete automation of all procedural steps. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 05700574034641 | GS1 |
Customer Contacts
- Phone
- +1-800-227-9770
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | No Device Sizes |