FDA UDI
In Commercial Distribution
🇺🇸 United States
Research and Diagnostic Systems
DI: 30815762021450
·
Model: FC402
·
RESEARCH AND DIAGNOSTIC SYSTEMS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
4
Basic Information
- Brand Name
- Research and Diagnostic Systems
- Primary DI
- 30815762021450
- Version / Model
- FC402
- Catalog Number
- FC402
- Company Name
- RESEARCH AND DIAGNOSTIC SYSTEMS, INC.
- Labeler DUNS
- 087248183
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 4
- Record Status
- Published
- Publish Date
- 2016-07-29
- Public Version
- 2
- Public Version Date
- 2018-03-29
- Public Version Status
- Update
- Public Device Record Key
- 32fd5581-fd63-4303-9718-f38bd6243f41
Device Description
StatusFlow Control: 4 x 2.5mL
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
- 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 |
|---|---|---|---|---|
| GKZ | Counter, Differential Cell | Hematology | 864.5220 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 57631 | T lymphocyte IVD, kit, fluorescent activated cell sorting/flow cytometry (FACS/Flow) | A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of T lymphocytes in a clinical specimen, using a fluorescent activated cell sorting/flow cytometry (FACS/Flow) method. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 30815762021450 | GS1 | ||||
| Unit of Use | 00815762021459 | GS1 |
Customer Contacts
- Phone
- 800-428-4246
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Total Volume | 10 | Milliliter |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius
- Type
- Handling Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius