DG Gel Extended Control
- Primary DI
- 07640137340605
- Brand
- DG Gel Extended Control
- Company
- Medion Grifols Diagnostics AG
- Model
- 4 x 6 ml
- Catalog number
- 213285
- Device description
- DG Gel Extended Control is intended to allow regular quality control of materials, work procedures and instrument procedures. For use with DG Gel 8 technique. For in vitro diagnostic use.
- Published
- 2016-09-26
- Public version status
- Update
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
Premarket Submissions#
| Submission | Supplement |
|---|---|
| BK140092 | 0 |
Premarket Details#
| Submission | Supplement | Device | Applicant | Decision date | Product code |
|---|---|---|---|---|---|
| BK140092 | 0 |
Identifiers And Packaging#
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 07640137340605 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | EAN-13 |
|---|---|---|
| 07640137340605 | 07640137340605 | 7640137340605 |
GMDN Terms#
| Term | Definition |
|---|---|
| Multiple immunohaematology test IVD, control | A collection of reagent red blood cells and/or immunoglobulins directed at red blood cell antigens that are supplied together and intended to be used when testing a clinical specimen to verify the performance of multiple immunohaematological tests. |
Sterilization Methods#
| Method |
|---|
Regulatory Flags#
- DUNS number
- 483287020
- Device count
- 1
- Kit
- true
- Lot or batch
- true
- Expiration date on label
- true
Other Devices From This Company#
| Primary DI | Brand | Model | Catalog | Published |
|---|---|---|---|---|
| 07640137342272 | Data-Cyte Plus P 0.8% | 11x4ml | 213688 | 2025-05-12 |
| 07640137341749 | Data-Cyte Plus 3% | 11x4 ml | 213231 | 2024-04-10 |
| 07640137341596 | Search-Cyte Pool 0.8% | 3x10 ml | 213289 | 2024-04-09 |
| 07640137340285 | Data-Cyte Plus 0.8% | 11x4 ml | 213654 | 2016-01-25 |
| 07640137340292 | Reverse-Cyte 3% (A1, B) | 2x10 ml | 213635 | 2016-01-27 |
| 07640137340308 | Reverse-Cyte 3% (A1, A2, B) | 3x10 ml | 213632 | 2016-01-27 |
| 07640137340315 | Reverse-Cyte 0.8% (A1, B) | 2x10 ml | 213660 | 2016-01-27 |
| 07640137340322 | Reverse-Cyte 0.8% (A1, A2, B) | 3x10 ml | 213662 | 2016-01-27 |
| 07640137340346 | Search-Cyte Plus 3% | 2x10 ml | 213639 | 2016-01-27 |
| 07640137340353 | Search-Cyte TCS 3% | 3x10 ml | 213631 | 2016-01-27 |
| 07640137340377 | Search-Cyte Plus 0.8% | 2x10 ml | 213656 | 2016-01-27 |
| 07640137340384 | Search-Cyte TCS 0.8% | 3x10 ml | 213655 | 2016-01-27 |
| 07640137340391 | Search-Cyte Pool 0.8% | 1x10 ml | 213663 | 2016-01-27 |
| 07640137341442 | Data-Cyte Extend 0.8% | 4 x 4ml | 213684 | 2024-04-22 |
| 07640137341459 | Data-Cyte Plus 2 0.8% | 11x4 ml | 213641 | 2024-04-22 |
| 07640137340278 | Data-Cyte Plus 3% | 11x4 ml | 213392 | 2016-01-25 |
| 07640137340339 | Search-Cyte I+II 3% | 2x10 ml | 213638 | 2016-01-27 |
| 07640137340360 | Search-Cyte I+II 0.8% | 2x10 ml | 213657 | 2016-01-27 |
| 07640137340582 | BBQA II | 1 kit | 213642 | 2016-09-26 |
| 07640137340599 | Coombs Control Cells | 1 x 10 ml | 213630 | 2016-09-26 |