Identity
- Trade Name
- MicroScan FDA UDI
- Generic Name
- General-microorganism antimicrobial susceptibility culture medium IVD FDA UDI
- Device Name
- Pos MIC Panel Type 34 FDA UDI
- Model / Reference
- B1017-216 FDA UDI
- Description
- Pos MIC Panel Type 34 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 15099590657550 FDA UDI
- 510(k) Number
- K003619 FDA UDIK010418 FDA UDIK020160 FDA UDIK020162 FDA UDIK043545 FDA UDIK050043 FDA UDIK081013 FDA UDIK081182 FDA UDIK123933 FDA UDIK131275 FDA UDIK150039 FDA UDIK152346 FDA UDIK862140 FDA UDIK863776 FDA UDIK870074 FDA UDIK874876 FDA UDIK934323 FDA UDIK945235 FDA UDIK972688 FDA UDIK993102 FDA UDI
- FDA Product Code
- LTW FDA UDILRG FDA UDIJWY FDA UDILTT 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
K003619 also covers:
K010418 also covers:
K020160 also covers:
K020162 also covers:
K043545 also covers:
K050043 also covers:
K081013 also covers:
K081182 also covers:
K123933 also covers:
K131275 also covers:
K152346 also covers:
K862140 also covers:
K863776 also covers:
K870074 also covers:
K874876 also covers:
K934323 also covers:
K945235 also covers:
K972688 also covers:
K993102 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Beckman Coulter, Inc.
Sources (1)
- FDA UDI 6634494d-9dad-46b3-9139-68501ff75325 34 fields · synced Jun 8, 2026