FDA UDI
In Commercial Distribution
🇺🇸 United States
MicroScan
DI: 15099590657352
·
Model: B1017-2
·
Beckman Coulter, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
20
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Basic Information
- Brand Name
- MicroScan
- Primary DI
- 15099590657352
- Version / Model
- B1017-2
- Company Name
- Beckman Coulter, Inc.
- Labeler DUNS
- 008254708
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 20
- Record Status
- Published
- Publish Date
- 2022-12-05
- Public Version
- 2
- Public Version Date
- 2026-01-16
- Public Version Status
- Update
- Public Device Record Key
- 67a4af79-ce91-4c28-b014-51c07f4356d0
Device Description
MicroScan Rapid Anaerobe ID Panel
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 |
|---|---|---|---|---|
| JSP | Kit, Anaerobic Identification | Microbiology | 866.2660 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 50417 | Multiple gram negative bacteria species culture isolate identification IVD, kit | A collection of reagents and other associated materials intended to be used for the differentiation and/or identification of one or multiple species of gram negative bacteria belonging to the Enterobacteriaceae or non-Enterobacteriaceae families, that have been isolated by culture from a clinical specimen. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 15099590657352 | GS1 | ||||
| Unit of Use | 05099590657355 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K862332 | 000 |