Identity
- Trade Name
- Diamedix FDA UDI
- Generic Name
- Multiple antibacterial minimum inhibitory concentration (MIC) IVD, kit FDA UDI
- Device Name
- 251-035 ProbeClean Concentration Kit" FDA UDI
- Model / Reference
- 251-035 FDA UDI
- Description
- 251-035 ProbeClean Concentration Kit" FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00817273020013 FDA UDI
- 510(k) Number
- K001767 FDA UDI
- FDA Product Code
- LJO FDA UDI
- GMDN Term
- Multiple antibacterial minimum inhibitory concentration (MIC) IVD, kit FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 866.3175 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Multiple antibacterial minimum inhibitory concentration (MIC) IVD, kit
Diamedix by Diamedix Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Multiple antibacterial minimum inhibitory concentration (MIC) IVD, kit.
- Liofilchem MTS (MIC Test Strip) — Liofilchem, Inc. · Class II
- Liofilchem MIC Test Strip — Liofilchem, Inc. · Class II
- Liofilchem MTS (MIC Test Strip) — Liofilchem, Inc. · Class II
- Liofilchem MTS (MIC Test Strip) — Liofilchem, Inc. · Class II
- Liofilchem MTS (MIC Test Strip) — Liofilchem, Inc. · Class II
- Liofilchem MTS (MIC Test Strip) — Liofilchem, Inc. · Class II
- Liofilchem MIC Test Strip (MTS) — Liofilchem, Inc. · Class II
- Liofilchem MTS (MIC Test Strip) — Liofilchem, Inc. · Class II
Cleared under the same submission
K001767 also covers:
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
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
- Diamedix Corp.
Sources (1)
- FDA UDI d822555d-2da1-4c67-9ebf-8d0a5ae9626d 36 fields · synced May 30, 2026