HemoScreen
GUDID 07290016991000
The HemoScreen is a quantitative automated hematology analyzer intended for in vitro diagnostic point-of-care (POC) use to classify and enumerate the following parameters for capillary and venous whole blood (K2 EDTA anticoagulated) in adults and children at least 2 years of age: WBC, RBC, HGB, HCT, MCV, MCH, MCHC, RDW, PLT, MPV NEUT%, NEUT#, LYMPH%, LYMP#, MONO%, MONO#, EO%, EO#, BASO%, and BASO#. The HemoScreen analyzer is indicated for use in clinical laboratories, and in POC settings
PIXCELL MEDICAL TECHNOLOGIES LTD
Haematological cell analyser IVD, automated| Primary Device ID | 07290016991000 |
| NIH Device Record Key | bbe1d947-a863-4aac-93d2-9253218ddead |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | HemoScreen |
| Version Model Number | HemoScreen 200 |
| Company DUNS | 532623092 |
| Company Name | PIXCELL MEDICAL TECHNOLOGIES LTD |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | false |
| Serial Number | true |
| Manufacturing Date | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 07290016991000 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K180020
FDA Product Code
| GKZ | Counter, Differential Cell |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2019-12-23 |
| Device Publish Date | 2019-01-14 |
On-Brand Devices [HemoScreen]
| 07290016991048 | A disposable unit used for the collection of the blood sample |
| 07290016991024 | A self-contained disposable unit in which a single blood sample is prepared and made ready for m |
| 07290016991000 | The HemoScreen is a quantitative automated hematology analyzer intended for in vitro diagnostic |
| 17290016991076 | A disposable unit used for the collection of the blood sample |
| 07290016991086 | The HemoScreen is a point-of-care (POC) automated hematology analyzer intended for the enumerati |
Trademark Results [HemoScreen]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 HEMOSCREEN 79169295 not registered Dead/Abandoned |
PIXCELL MEDICAL TECHNOLOGIES LTD 2015-05-06 |
 HEMOSCREEN 74229798 not registered Dead/Abandoned |
FUJISAWA PHARMACEUTICAL CO., LTD. 1991-12-12 |
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