FDA UDI
In Commercial Distribution
🇺🇸 United States
CELLTRACKS AUTOPREP
DI: 10888385000665
·
Model: 9541
·
MENARINI SILICON BIOSYSTEMS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- CELLTRACKS AUTOPREP
- Primary DI
- 10888385000665
- Version / Model
- 9541
- Catalog Number
- 9541
- Company Name
- MENARINI SILICON BIOSYSTEMS, INC.
- Labeler DUNS
- 057722858
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-07-10
- Public Version
- 2
- Public Version Date
- 2022-09-16
- Public Version Status
- Update
- Public Device Record Key
- 2efa8255-9c11-4d52-bb3d-1bc5bfb7975d
Device Description
CELLTRACKS AUTOPREP - EU ROHS Compliant
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
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- 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 |
|---|---|---|---|---|
| NQI | System, Immunomagnetic, Circulating Cancer Cell, Enumeration | Immunology | 866.6020 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 57871 | Specimen processing instrument IVD | An electrically-powered instrument or platform intended to be used for the automated or semi-automated pre-analytical preparation of a clinical specimen (excluding specimens for microbial culture), which may include the sampling, diluting, and/or aliquoting of clinical specimens and/or any post-analytical processing required, including labelling, storage and/or location data. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 10888385000665 | GS1 |
Customer Contacts
- Phone
- 2153468312
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K122821 | 000 |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Fragile
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 50 Degrees Celsius