Identity
- Trade Name
- Bio-Rad Laboratories, Inc. FDA UDI
- Generic Name
- Buffered sample diluent IVD, manual FDA UDI
- Device Name
- Diluent for Rubella, Toxo, CMV, HSV, VZV, Measles, Mumps, EBNA and EB EAD IgG EIA Tests FDA UDI
- Model / Reference
- 25186 FDA UDI
- Description
- Diluent for Rubella, Toxo, CMV, HSV, VZV, Measles, Mumps, EBNA and EB EAD IgG EIA Tests FDA UDI
Identifiers
- Catalog Number
- 25186 FDA UDI
- Primary DI / UDI-DI
- 00847865011136 FDA UDI
- 510(k) Number
- K954191 FDA UDI
- FDA Product Code
- LFZ FDA UDI
- GMDN Term
- Buffered sample diluent IVD, manual FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 866.3175 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
Dimensions & Sizes
- Size
- Total Volume — 25 Milliliter FDA UDI
Category: Buffered sample diluent IVD, manual
Bio-Rad Laboratories, Inc. by Bio-Rad Laboratories — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K954191 also covers:
- ASI CMV IgG EIA Test — Arlington Scientific, Inc.
- Bio-Rad Laboratories, Inc. — Bio-Rad Laboratories
- Bio-Rad Laboratories, Inc. — Bio-Rad Laboratories
- Bio-Rad Laboratories, Inc. — Bio-Rad Laboratories
- Bio-Rad Laboratories, Inc. — Bio-Rad Laboratories
- Pointe Scientific, Inc. CMV IgG — POINTE SCIENTIFIC, INC.
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
- Bio-Rad Laboratories
Sources (1)
- FDA UDI f2b027d8-d740-4838-a090-3b2b65671e9e 38 fields · synced May 31, 2026