Identity
- Trade Name
- ComASP FDA UDI
- Generic Name
- Antibacterial minimum inhibitory concentration (MIC) IVD FDA UDI
- Model / Reference
- ComASP Cefiderocol 0.008-128 FDA UDI
Identifiers
- Catalog Number
- 75009U FDA UDI
- Primary DI / UDI-DI
- 08058951160436 FDA UDI
- 510(k) Number
- K230479 FDA UDI
- FDA Product Code
- JWY FDA UDI
- GMDN Term
- Antibacterial minimum inhibitory concentration (MIC) 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
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Antibacterial minimum inhibitory concentration (MIC) IVD
ComASP by Liofilchem, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 |
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Manufacturer
- Manufacturer
- Liofilchem, Inc.
Sources (1)
- FDA UDI 72658733-a2dd-4847-a5ac-19dc4816de2a 34 fields · synced May 30, 2026