GEM CVP (Calibration Valuation Product) 3 Hematocrit
Catalogue number 00025000130, listed by Instrumentation Laboratory SPA, Italy, under Control, Hematocrit. 1 manufacturer in China is registered for this product code.
1manufacturer
1catalogue number
Who Else Makes It
Registered in Guangdong.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Edan Instruments, Inc. | Shenzhen | Guangdong | Contract manufacturer | 56 |
Record
| Listed by | Instrumentation Laboratory SPA, Italy |
|---|---|
| FDA product code | GLK |
| Device type | Control, Hematocrit |
| Device class | Class 2 |
| Regulation | 21 CFR 864.8625 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K112995 |
| Record published | 2016-09-23 |
| Record revised | 2021-07-13 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Storage | Special storage condition: CVP 1 and 2: Unopened ampules are stored at 2-8° C, or up to 8 months at room temperature (15- 25° C), CVP 3 and 4: Unop; Storage environment temperature 2 to 8 °C |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 00025000130 | 10 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Eurotrol | Eurotrol B.V. | 4 |
| Hematocrit Control | Edan Instruments, Inc. | 2 |
| ChemSTAT Hematocrit Evaluator 1 | Instrumentation Laboratory SPA | 1 |
| HemataChek High Control | Separation Technology, Inc. | 1 |
| GEM Hematocrit Evaluator 2 | Instrumentation Laboratory SPA | 1 |
| Hct Check – High Level | Instrumentation Laboratory SPA | 1 |
| HemataChek, Low, Normal, High Control | Separation Technology, Inc. | 1 |
| GEM critCheck | Instrumentation Laboratory SPA | 1 |
| GEM Hematocrit Evaluator 1 | Instrumentation Laboratory SPA | 1 |
| Rapidqc® Hct Level A | Siemens Healthcare Diagnostics Inc | 1 |
| Hct Check – Low Level | Instrumentation Laboratory SPA | 1 |
| HemataChek Low Control | Separation Technology, Inc. | 1 |
Showing 12 of 23. All products under Control, Hematocrit
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.