FDA UDI
In Commercial Distribution
🇺🇸 United States
r-Control RBC and PLT
DI: 08809317541143
·
Model: ADRC 020
·
NanoEnTek, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- r-Control RBC and PLT
- Primary DI
- 08809317541143
- Version / Model
- ADRC 020
- Catalog Number
- ADRC 020
- Company Name
- NanoEnTek, Inc.
- Labeler DUNS
- 687910463
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-12-08
- Public Version
- 1
- Public Version Date
- 2021-12-16
- Public Version Status
- New
- Public Device Record Key
- f68d0407-ee84-49d1-b2b7-3af64a10cb82
Device Description
The r-Control RBC and PLT consists of red blood cell (RBC) Low & RBC High process controls and platelet (PLT) Low & PLT High process controls. It is intended for use with ADAM-rWBC Kit to monitor the process for enumeration of residual leukocytes in leukocyte reduced RBC and PLT products, including dilution, staining, instrument setup, and white blood cell (WBC) enumeration. For in vitro diagnostic use only.
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 |
|---|---|---|---|---|
| MZG | Test, Residual, Wbc In Leukoreduced Blood | Hematology | 864.8625 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 56225 | White blood cell 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 white blood cell (leukocyte) count and/or the differential of white cell types in a clinical specimen. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08809317541143 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| BK210621 | 0 |