FDA UDI
In Commercial Distribution
🇺🇸 United States
8-key Manual Differential Counter
DI: 00664816003558
·
Model: CTL-GEN8-M777
·
LW SCIENTIFIC, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- 8-key Manual Differential Counter
- Primary DI
- 00664816003558
- Version / Model
- CTL-GEN8-M777
- Catalog Number
- CTL-GEN8-M777
- Company Name
- LW SCIENTIFIC, INC.
- Labeler DUNS
- 785335381
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-06-24
- Public Version
- 2
- Public Version Date
- 2023-02-20
- Public Version Status
- Update
- Public Device Record Key
- 135ada76-2ff0-469d-b83e-3482e5c437ab
Device Description
Differential Counter, 8 key, manual
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- 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
- Yes
- Has Serial Number
- Yes
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- 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 |
|---|---|---|---|---|
| GLG | Platelet Counting, Manual | Hematology | 864.6160 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 64079 | White blood cell differential count recorder IVD, non-powered | A non-powered device intended to be used by a healthcare professional to manually record and display haematological cell counts of white blood cell populations in a clinical specimen, as observed under a microscope. It consists of multiple mechanical tally counters with a lever representing each white blood cell type (e.g., basophil, eosinophil, lympocyte) which the operator depresses to record an observed cell type. Totals for population counts are displayed on the device and used to subsequently calculate the percentages for each population. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00664816003558 | GS1 |