FDA UDI
In Commercial Distribution
🇺🇸 United States
ADAM-rWBC2
DI: 08809317540498
·
Model: ADAM-rWBC2
·
NanoEnTek, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- ADAM-rWBC2
- Primary DI
- 08809317540498
- Version / Model
- ADAM-rWBC2
- Catalog Number
- ADAM-rWBC2
- Company Name
- NanoEnTek, Inc.
- Labeler DUNS
- 687910463
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-06-19
- Public Version
- 2
- Public Version Date
- 2024-07-23
- Public Version Status
- Update
- Public Device Record Key
- 53b7eda2-fd13-4646-a5f2-fec93650fd89
Device Description
ADAM-rWBC2 is a device to count white blood cell. It is used with ADAM-rWBC Kit.
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
- Yes
- Has Lot/Batch Number
- No
- 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 |
|---|---|---|---|---|
| GKZ | Counter, Differential Cell | Hematology | 864.5220 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 55858 | White blood cell count IVD, kit, cell count | A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative determination of the white blood cell (leukocyte) count and/or the differential of white cell types in a clinical specimen using a manual, semi-automated or automated cell count method. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08809317540498 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| BK120068 | 0 |