FDA UDI
In Commercial Distribution
🇺🇸 United States
LW Scientific
DI: 00664816002179
·
Model: ZCP-RT16-7PCR
·
LW SCIENTIFIC, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- LW Scientific
- Primary DI
- 00664816002179
- Version / Model
- ZCP-RT16-7PCR
- Catalog Number
- ZCP-RT16-7PCR
- Company Name
- LW SCIENTIFIC, INC.
- Labeler DUNS
- 785335381
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-04-08
- Public Version
- 1
- Public Version Date
- 2021-04-16
- Public Version Status
- New
- Public Device Record Key
- 32ac65d0-dcf9-4bce-80fc-4e4ce1ce8694
Device Description
Rotor, 16-place PCR, holds 2 strips, for ZipCombo
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
- Yes
- 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 |
|---|---|---|---|---|
| JQC | Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use | Clinical Chemistry | 862.2050 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 37532 | Centrifuge rotor, fixed angle | A device, commonly called the rotor, or rotor head, used as a component in a centrifuge. It is designed with the tube holding bores formed at a pre-set angle and pattern. It is horizontally attached at the top of the vertical shaft which is part of the electrically-powered drive unit and the samples to be centrifuged are placed in this rotor. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00664816002179 | GS1 |