MicroScan
- Primary DI
- 15099590799250
- Brand
- MicroScan
- Company
- Beckman Coulter, Inc.
- Model
- V5.03 PU11
- Catalog number
- D23354
- Device description
- MicroScan LabPro V5.03 Panel Update 11 DVD Kit (US)
- Published
- 2025-12-08
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- OTC
- false
- Sterile
- false
- Single use
- false
Related Records
Product Codes
| Code | Name |
|---|---|
| OUG | Medical Device Data System |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|---|---|---|
| OUG | Medical Device Data System | General Hospital | 1 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 15099590799250 | Primary | GS1 | 0 |
GMDN Terms
| Term | Definition |
|---|---|
| Microorganism identification/antimicrobial-susceptibility analyser IVD | An electrically-powered automated or semi-automated laboratory instrument intended to be used for the identification of bacteria and/or yeast isolated from clinical specimens and for the determination of their antimicrobial susceptibility profile using morphology, substrate utilization and/or biochemical reactivity and by monitoring growth rates and/or determining endpoint growth, against a range of antimicrobials. Growth detection technology used may include immunoassay, colorimetry, fluorimetry, chromatography and/or carbon dioxide production. |
Sterilization Methods
| Method |
|---|
Regulatory Flags
- DUNS number
- 008254708
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- true
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- true
- Serial number
- false
- Manufacturing date on label
- true
- Expiration date on label
- false
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- false
Other Devices From This Company
| Primary DI | Brand | Model | Catalog | Published |
|---|---|---|---|---|
| 15099590806255 | ACCESS HBsAg | D22913 | 2026-01-16 | |
| 15099590806262 | ACCESS HBsAg Confirmatory | D22914 | 2026-01-16 | |
| 15099590806279 | Access HBsAg CALIBRATOR | D22915 | 2026-01-16 | |
| 15099590806286 | ACCESS HBsAg QC | D22916 | 2026-01-16 | |
| 15099590806415 | ACCESS anti-HAV | D25831 | 2026-01-16 | |
| 15099590806422 | ACCESS anti-HAV CALIBRATOR | D25832 | 2026-01-16 | |
| 15099590806439 | ACCESS anti-HAV QC | D25833 | 2026-01-16 | |
| 15099590799717 | MicroScan | V5.03 | D23824 | 2025-12-17 |
| 15099590799724 | MicroScan | V5.03 | D23825 | 2025-12-17 |
| 15099590799755 | MicroScan | V5.03 | D23828 | 2025-12-17 |
| 15099590799762 | MicroScan | V5.03 | D23829 | 2025-12-17 |
| 05099590798973 | MicroScan | D18443 | D18443 | 2025-12-08 |
| 05099590798980 | MicroScan | D18444 | D18444 | 2025-12-08 |
| 05099590798997 | MicroScan | D18445 | 2025-12-08 | |
| 05099590799000 | MicroScan | D18446 | 2025-12-08 | |
| 05099590799017 | MicroScan | D18447 | 2025-12-08 | |
| 05099590799024 | MicroScan | D18448 | 2025-12-08 | |
| 15099590799243 | MicroScan | V5.03 PU11E | D23352 | 2025-12-08 |
| 15099590807146 | MicroScan | V5.03 DD07E | D33604 | 2025-12-08 |
| 15099590754488 | Access Total T4 II | C69047 | C69047 | 2025-09-19 |
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| 15099590807146 | MicroScan | Beckman Coulter, Inc. | OUG | 2025-12-08 |
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