Identity
- Trade Name
- Bio-Rad Laboratories, Inc. FDA UDI
- Generic Name
- Isotonic saline reagent IVD FDA UDI
- Device Name
- PBS For Immunofluorescent Assays, 11.34 gm FDA UDI
- Model / Reference
- 31098 FDA UDI
- Description
- PBS For Immunofluorescent Assays, 11.34 gm FDA UDI
Identifiers
- Catalog Number
- 31098 FDA UDI
- Primary DI / UDI-DI
- 00847865001731 FDA UDI
- 510(k) Number
- K810863 FDA UDI
- FDA Product Code
- DBM FDA UDI
- GMDN Term
- Isotonic saline reagent IVD FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 866.5090 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
- Weight — 11.34 Gram FDA UDI
Category: Isotonic saline reagent IVD
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
K810863 also covers:
- Bio-Rad Laboratories, Inc. — Bio-Rad Laboratories
- Bio-Rad Laboratories, Inc. — Bio-Rad Laboratories
- Bio-Rad Laboratories, Inc. — Bio-Rad Laboratories
- Kallestad — Bio-Rad Laboratories
- Kallestad — Bio-Rad Laboratories
- Kallestad — Bio-Rad Laboratories
- Kallestad — Bio-Rad Laboratories
- Kallestad — Bio-Rad Laboratories
- Kallestad — Bio-Rad Laboratories
- Kallestad — Bio-Rad Laboratories
- Kallestad — Bio-Rad Laboratories
- Kallestad — Bio-Rad Laboratories
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 201c0a3d-4305-45e9-a564-ccaaede48d72 38 fields · synced Jun 1, 2026