FDA UDI
In Commercial Distribution
🇺🇸 United States
MicroScan
DI: 15099590798994
·
Model: D18445
·
Beckman Coulter, Inc.
Product Codes
5
GMDN Terms
1
Identifiers
2
Pkg Device Count
20
Let the assistant research this device
The Research Assistant compiles product codes, classification, clearances and adverse events for this device — and cites every record.
Free to try · every answer cites its records
Basic Information
- Brand Name
- MicroScan
- Primary DI
- 15099590798994
- Version / Model
- D18445
- Company Name
- Beckman Coulter, Inc.
- Labeler DUNS
- 008254708
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 20
- Record Status
- Published
- Publish Date
- 2025-12-08
- Public Version
- 1
- Public Version Date
- 2025-12-16
- Public Version Status
- New
- Public Device Record Key
- 16043c91-6d1d-4b7a-9dc1-5072d60786c2
Device Description
MicroScan Neg Combo 105
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- 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
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| JWY | Manual Antimicrobial Susceptibility Test Systems | Microbiology | 866.1640 | 2 |
| LRG | Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems | Microbiology | 866.1640 | 2 |
| LTT | Panels, Test, Susceptibility, Antimicrobial | Microbiology | 866.1640 | 2 |
| LTW | Susceptibility Test Cards, Antimicrobial | Microbiology | 866.1640 | 2 |
| LQM | Gram Negative Identification Panel | Microbiology | 866.2660 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58605 | General-microorganism antimicrobial susceptibility culture medium IVD | A non-selective culture medium intended to be used to perform diagnostic antimicrobial susceptibility testing on general microorganisms isolated from a clinical specimen. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Unit of Use | 05099590798997 | GS1 | ||||
| Primary | 15099590798994 | GS1 |