Identity
- Trade Name
- MicroScan FDA UDI
- Generic Name
- General-microorganism antimicrobial susceptibility culture medium IVD FDA UDI
- Device Name
- ESBL Plus ESBL Confirmation Panel FDA UDI
- Model / Reference
- B1027-101 FDA UDI
- Description
- ESBL Plus ESBL Confirmation Panel FDA UDI
Identifiers
- Primary DI / UDI-DI
- 15099590659608 FDA UDI
- 510(k) Number
- K020037 FDA UDIK061536 FDA UDIK192355 FDA UDIK201423 FDA UDIK202343 FDA UDIK862140 FDA UDIK863776 FDA UDIK870074 FDA UDIK941030 FDA UDIK962150 FDA UDIK971376 FDA UDI
- FDA Product Code
- LTT FDA UDILRG FDA UDIJWY FDA UDILTW FDA UDI
- GMDN Term
- General-microorganism antimicrobial susceptibility culture medium IVD FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 866.1640 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
Yes
Implantable
No
Contains Latex
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
No
Category: General-microorganism antimicrobial susceptibility culture medium IVD
MicroScan by Beckman Coulter, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K020037 also covers:
K061536 also covers:
K192355 also covers:
K201423 also covers:
K202343 also covers:
K862140 also covers:
K863776 also covers:
K870074 also covers:
K962150 also covers:
K971376 also covers:
Authorization Coverage (1 country)
Regulatory Authorizations
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Beckman Coulter, Inc.
Sources (1)
- FDA UDI 670a1386-fe05-4088-a4ce-51e32fcfa58a 34 fields · synced Jun 8, 2026