FDA UDI
In Commercial Distribution
🇺🇸 United States
CellSearch
DI: 10888385000016
·
Model: 7900001
·
MENARINI SILICON BIOSYSTEMS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- CellSearch
- Primary DI
- 10888385000016
- Version / Model
- 7900001
- Catalog Number
- 7900001
- Company Name
- MENARINI SILICON BIOSYSTEMS, INC.
- Labeler DUNS
- 057722858
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-22
- Public Version
- 3
- Public Version Date
- 2019-02-07
- Public Version Status
- Update
- Public Device Record Key
- 2e1c426c-456a-4cd6-8087-1510e5179700
Device Description
Circulating Tumor Cell Kit (Epithelial)
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- 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
- Yes
- 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 |
|---|---|---|---|---|
| NQI | SYSTEM, IMMUNOMAGNETIC, CIRCULATING CANCER CELL, ENUMERATION | Immunology | 866.6020 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 56915 | Multiple CD cell marker IVD, kit, enzyme immunohistochemistry | A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of multiple cluster of differentiation (CD) cell markers in a clinical specimen, including associated percentage, calculated scores, and/or enumeration of specific cell populations, using an enzyme immunohistochemistry method. It is used as an aid in the diagnosis/prognosis of conditions associated with different CD cell markers (e.g., colon cancer). | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 10888385000016 | GS1 |
Customer Contacts
- Phone
- +1(877)837-4339
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius
- Type
- Special Storage Condition, Specify
- Special Conditions
- Protect reagents from exposure to sunlight.