Identity
- Trade Name
- McFarland Standard FDA UDI
- Generic Name
- McFarland standard IVD FDA UDI
- Device Name
- McFarland Standard is a series of standards of different opacity, allowing the estimation of the density of bacterial suspensions. FDA UDI
- Model / Reference
- 70900 FDA UDI
- Description
- McFarland Standard is a series of standards of different opacity, allowing the estimation of the density of bacterial suspensions. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 03573026100087 FDA UDI
- FDA Product Code
- JTO FDA UDI
- GMDN Term
- McFarland standard IVD FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 866.2660 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
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: McFarland standard IVD
McFarland Standard by Biomerieux , Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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
- Biomerieux , Inc.
Sources (1)
- FDA UDI 821f2f39-2987-4c4a-922d-fe0c03ca8aec 34 fields · synced Jun 1, 2026