FDA UDI
In Commercial Distribution
🇺🇸 United States
Yingtai
DI: 06976301910154
·
Model: cytoprep-2
·
Changsha Yingtai Instrument Co., Ltd
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Yingtai
- Primary DI
- 06976301910154
- Version / Model
- cytoprep-2
- Company Name
- Changsha Yingtai Instrument Co., Ltd
- Labeler DUNS
- 544727865
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-02-28
- Public Version
- 1
- Public Version Date
- 2025-03-10
- Public Version Status
- New
- Public Device Record Key
- e85a524d-5bf7-4e39-b0c8-5c98b64bc103
Device Description
Centrifuge is an experimental device that utilizes centrifugal force to separate substances of different densities within a liquid sample. It is widely used in fields such as biomedical science, chemical analysis, molecular biology, and industrial production. By rapidly spinning samples to create a density gradient, centrifuges provide efficient solutions for sample extraction, purification, and concentration. They can generally be categorized into high-speed or low-speed centrifuges, refrigerated or non-refrigerated centrifuges, and floor-standing or benchtop centrifuges.
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
- No
- 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 |
|---|---|---|---|---|
| JQC | Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use | Clinical Chemistry | 862.2050 | 1 |
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 | 06976301910154 | GS1 |