Identity
- Trade Name
- Strep B Carrot Broth™ FDA UDI
- Generic Name
- Differential/selective broth culture medium IVD FDA UDI
- Device Name
- Strep B Carrot Broth™ One-Step, for the detection of hemolytic Group B Strep in pregnant women, no reaction tile required, 12x80mm plastic tube, compatible with the WASP® instrument, 100 tubes per box Strep B Carrot Broth™ One-Step is a selective and differential medium which is intended for the detection of Group B Streptococcus (GBS) from anovaginal specimens collected from pregnant women. The medium is used as an aid in the qualitative determination of GBS colonization in pregnant women. The color change reaction from white to orange is representative of a positive result for presence of hemolytic GBS. FDA UDI
- Model / Reference
- Z44BX FDA UDI
- Description
- Strep B Carrot Broth™ One-Step, for the detection of hemolytic Group B Strep in pregnant women, no reaction tile required, 12x80mm plastic tube, compatible with the WASP® instrument, 100 tubes per box Strep B Carrot Broth™ One-Step is a selective and differential medium which is intended for the detection of Group B Streptococcus (GBS) from anovaginal specimens collected from pregnant women. The medium is used as an aid in the qualitative determination of GBS colonization in pregnant women. The color change reaction from white to orange is representative of a positive result for presence of hemolytic GBS. FDA UDI
Identifiers
- Catalog Number
- Z44BX FDA UDI
- Primary DI / UDI-DI
- 00819398028523 FDA UDI
- 510(k) Number
- K170586 FDA UDI
- FDA Product Code
- PQZ FDA UDI
- GMDN Term
- Differential/selective broth culture medium IVD FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 866.2360 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
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: Differential/selective broth culture medium IVD
Strep B Carrot Broth™ by Hardy Diagnostics — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K170586 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 I | Pending data |
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Manufacturer
- Manufacturer
- Hardy Diagnostics
Sources (1)
- FDA UDI 5a62da3a-fe4b-49f6-96b0-8873001059f0 37 fields · synced May 30, 2026