Identity
- Trade Name
- Todd Hewitt Broth + Antibiotics EUDAMEDTODD H-T FDA UDI
- Generic Name
- Differential/selective broth culture medium IVD FDA UDI
- Device Name
- Todd Hewitt Broth + Antibiotics EUDAMEDselective enrichment broth for the detection of group B streptococci in pregnant women. FDA UDI
- Model / Reference
- 42116 EUDAMEDTODD H-T FDA UDI
- Description
- selective enrichment broth for the detection of group B streptococci in pregnant women. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 03573026118723 EUDAMEDFDA UDI
- Basic UDI-DI
- 357302BUDI000105SR EUDAMED
- Unit of Use DI
- 03573026598518 EUDAMED
- FDA Product Code
- JSD FDA UDI
- EMDN Code
- W0104010206 MEDIA IN TUBES (SOLID & LIQUID) EUDAMED
- GMDN Term
- Differential/selective broth culture medium IVD FDA UDI
Classification
- Device Class
- Class A EUDAMEDClass I FDA UDI
- Regulation Number
- 866.2360 FDA UDI
- Market of Registration
- France EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
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
Yes
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
Category: Differential/selective broth culture medium IVD
Todd H-T by Biomerieux , Inc. — Class I — IVDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
IVDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | IVDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Biomerieux , Inc.
Sources (2)
- FDA UDI 8a94d4e8-db84-46c6-897a-f4e127e03467 34 fields · synced Jul 12, 2026
- EUDAMED 361582aa-8a3e-4bf6-ab2c-37952d04b4b5 61 fields · synced Jul 12, 2026