FDA UDI
In Commercial Distribution
🇺🇸 United States
Research and Diagnostic Systems
DI: 00815762026508
·
Model: CL037
·
RESEARCH AND DIAGNOSTIC SYSTEMS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Research and Diagnostic Systems
- Primary DI
- 00815762026508
- Version / Model
- CL037
- Catalog Number
- CL037
- Company Name
- RESEARCH AND DIAGNOSTIC SYSTEMS, INC.
- Labeler DUNS
- 087248183
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-06-04
- Public Version
- 1
- Public Version Date
- 2025-06-12
- Public Version Status
- New
- Public Device Record Key
- 8fb85cd0-b56e-4012-8c89-b0dc6f91cfac
Device Description
CBC-LINE Kit: 6 x 3mL (6 vials each of the various levels) RBC Levels 1-6, WBC Levels 1,3,6,8,10,11 PLT Levels 1,4,7,10,12,13 Low Levels 1-6
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- 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 |
|---|---|---|---|---|
| JPK | Mixture, Hematology Quality Control | Hematology | 864.8625 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 55866 | Full blood count IVD, control | A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative determination of multiple whole blood cell parameters in a clinical specimen [also known as complete blood count (CBC)]. Test components may include white cell count and differential, red cell count, and calculation of red cell parameters and/or platelet count, as well as other general blood evaluation tests [e.g., C-reactive protein (CRP)]. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00815762026508 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K942822 | 000 |