Identity
- Trade Name
- MicroScan FDA UDI
- Generic Name
- General-microorganism antimicrobial susceptibility culture medium IVD FDA UDI
- Device Name
- Detect Neg MIC 2 FDA UDI
- Model / Reference
- B1020-102B FDA UDI
- Description
- Detect Neg MIC 2 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 15099590699413 FDA UDI
- 510(k) Number
- K061687 FDA UDIK083262 FDA UDIK172255 FDA UDIK172337 FDA UDIK862140 FDA UDIK863776 FDA UDIK883076 FDA UDIK955910 FDA UDIK962150 FDA UDIK970676 FDA UDIK971376 FDA UDI
- FDA Product Code
- OTT FDA UDILTT FDA UDIJWY FDA UDILTW FDA UDI
- GMDN Term
- General-microorganism antimicrobial susceptibility culture medium IVD FDA UDI
Classification
- Device Class
- N 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
Yes
Category: General-microorganism antimicrobial susceptibility culture medium IVD
MicroScan by Beckman Coulter, Inc. — Class N — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K061687 also covers:
K083262 also covers:
K862140 also covers:
K863776 also covers:
K883076 also covers:
K955910 also covers:
K962150 also covers:
K970676 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 N | Pending data |
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Manufacturer
- Manufacturer
- Beckman Coulter, Inc.
Sources (1)
- FDA UDI 5282f8c6-da35-4973-804d-6cdefc93e5e8 34 fields · synced Jun 8, 2026