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Oxoid Eravacycline Disc (20ug) ERV20 Antimicrobial Susceptibility Test Discs
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- Oxoid Eravacycline Disc (20ug) ERV20 Antimicrobial Susceptibility Test Discs FDA UDI
- Generic Name
- Antibacterial susceptibility testing disc IVD FDA UDI
- Model / Reference
- CT1954B FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05032384516018 FDA UDI
- 510(k) Number
- K193508 FDA UDI
- FDA Product Code
- JTN FDA UDI
- GMDN Term
- Antibacterial susceptibility testing disc IVD FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 866.1620 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
No
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 susceptibility testing disc IVD
Oxoid Eravacycline Disc (20ug) ERV20 Antimicrobial Susceptibility Test Discs by Oxoid Limited — Class II — FDA UDI — listed in FDA GUDID
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Also classified as Antibacterial susceptibility testing disc IVD.
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- BD BBL™ Sensi-Disc™ Bacitracin 2 units — BECTON DICKINSON AND COMPANY · Class II
- BD BBL™ Sensi-Disc™ Streptomycin 300 µg — BECTON DICKINSON AND COMPANY · Class II
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
- Oxoid Limited
Sources (1)
- FDA UDI ec37879e-fd10-4045-a542-5f80b030566c 34 fields · synced May 30, 2026