FDA UDI
In Commercial Distribution
🇺🇸 United States
ADAM-rWBC Kit
DI: 08809317540269
·
Model: AD1K-050
·
NanoEnTek, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- ADAM-rWBC Kit
- Primary DI
- 08809317540269
- Version / Model
- AD1K-050
- Catalog Number
- AD1K-050
- Company Name
- NanoEnTek, Inc.
- Labeler DUNS
- 687910463
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-30
- Public Version
- 4
- Public Version Date
- 2024-07-23
- Public Version Status
- Update
- Public Device Record Key
- f15d674d-d890-4b79-840f-c0501c3ac977
Device Description
It is used for the quantitative determination of the residual white blood cell (leukocyte) count in a human specimen using ADAM-rWBC.
Device Characteristics
- Single Use
- Yes
- 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
- Yes
- 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 |
|---|---|---|---|---|
| 55859 | White blood cell count IVD, reagent | A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08809317540269 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| BK120015 | 0 |
| BK120068 | 0 |