FDA UDI
In Commercial Distribution
🇺🇸 United States
IH-Centrifuge L
DI: 07611969226320
·
Model: 009301
·
Bio-Rad Medical Diagnostics GmbH
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- IH-Centrifuge L
- Primary DI
- 07611969226320
- Version / Model
- 009301
- Company Name
- Bio-Rad Medical Diagnostics GmbH
- Labeler DUNS
- 312576506
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-04-05
- Public Version
- 5
- Public Version Date
- 2022-06-10
- Public Version Status
- Update
- Public Device Record Key
- 0d5234fc-998d-4258-ab22-72fed07a86b8
Device Description
IH-Centrifuge L for centrifugation of IH-System gel cards and/or test tubes.
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 |
|---|---|---|---|---|
| PBC | Manual Blood Grouping And Antibody Test Systems | Hematology | 864.9175 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 36465 | General-purpose centrifuge IVD | An electrically-powered device intended to be used to separate the components of multiple types and various volumes of clinical suspensions using centrifugal force. It is a self-contained unit with an electric motor, a vertical shaft, and a horizontal rotor attached to the upper end. It is typically used to centrifuge various types of clinical specimens, either alone or after addition of reagents or other additives, for subsequent in vitro diagnostic analysis. It may additionally have refrigeration capabilities to perform temperature-sensitive procedures. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 07611969226320 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| BK170065 | 0 |