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Tryptone Soya Agar
EUDAMEDFDA UDIClass A (EU MDR)
Ref PO0163ARef BO0330VRef CM0131T
by Oxoid Ltd
Identity
- Trade Name
- TRYPTONE SOYA AGAR EUDAMEDTRYPTONE SOYA BROTH FDA UDI
- Generic Name
- Basic/simple nutrient agar culture medium IVD FDA UDI
- Device Name
- TRYPTONE SOYA AGAR EUDAMED
- Model / Reference
- PO0163A EUDAMEDBO0330V EUDAMEDCM0131T EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 05032384018079 EUDAMED05032384018819 EUDAMED05032384001798 EUDAMEDFDA UDI
- Basic UDI-DI
- 5032384TryptSoyaAgarOL6B EUDAMED5032384TryptSoyaAgarOL2R8 EUDAMED
- FDA Product Code
- JSC FDA UDI
- EMDN Code
- W0104010405 NON-CHROMOGENIC MEDIA (PLATES) EUDAMEDW0104010306 CULTURE MEDIA IN BOTTLES EUDAMEDW0104010101 DEHYDRATED CULTURE MEDIA (DCM) EUDAMED
- GMDN Term
- Basic/simple nutrient agar culture medium IVD FDA UDI
Classification
- Device Class
- Class A EUDAMEDClass I FDA UDI
- Regulation Number
- 866.2350 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Human Tissues
No
EUDAMED
Animal Tissues
Yes
EUDAMED
Microbial Substances
Yes
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Tryptone Soya Agar by Oxoid Ltd — Class A — IVDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/IVDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 5032384TryptSoyaAgarOL6B | Class A | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class A | Pending data |
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Manufacturer
- Manufacturer
- Oxoid Ltd
- EUDAMED SRN
- GB-MF-000016914
- Authorised Representative
- Thermo Fisher Diagnostics B.V. NL-AR-000013157
Sources (4)
- EUDAMED 365fceeb-501d-4cb4-9ffd-f7a56e72765e 61 fields · synced Jul 24, 2026
- EUDAMED e3b15e48-e114-471d-8546-ca18f6589475 61 fields · synced May 19, 2026
- EUDAMED 94c4189a-662f-4144-a990-6ac1279e2995 61 fields · synced May 19, 2026
- FDA UDI ec3a8702-d6cf-4fac-b2b8-ec4c78c16b4a 32 fields · synced May 30, 2026