Identity
- Trade Name
- Dade Owren's Veronal Buffer FDA UDI
- Generic Name
- Buffered sample diluent IVD FDA UDI
- Device Name
- Dilution buffer for coagulation testing FDA UDI
- Model / Reference
- 10873839 FDA UDI
- Description
- Dilution buffer for coagulation testing FDA UDI
Identifiers
- Catalog Number
- 10873839 FDA UDI
- Primary DI / UDI-DI
- 00630414640273 FDA UDI
- 510(k) Number
- K050928 FDA UDI
- FDA Product Code
- KQJ FDA UDI
- GMDN Term
- Buffered sample diluent IVD FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 864.7340 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
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: Buffered sample diluent IVD
Dade Owren's Veronal Buffer by Siemens Healthcare Diagnostics Products Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Buffered sample diluent IVD.
- ADVIA Centaur® ThCG DIL — Siemens Healthcare Diagnostics · Class II
- C & S Diluent — Precision Biologic · Class II
- Dimension® Sample Diluent — Siemens Healthcare Diagnostics · Class II
- Lumipulse G Specimen Diluent 2 — FUJIREBIO INC. · Class I
- ADVIA Centaur® T4 DIL — Siemens Healthcare Diagnostics · Class II
- Dimension® Purified Water Diluent — Siemens Healthcare Diagnostics · Class I
- ADVIA Centaur® VitD Diluent Bottle — Siemens Healthcare Diagnostics · Class II
- ARCHITECT — Abbott Laboratories, Inc. · Class II
Cleared under the same submission
K050928 also covers:
- Dade CA System Buffer — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
- Dade Thrombin Reagent — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
- Dade Thrombin Reagent — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
- Dade® CA System Buffer — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
- Dade® Owren's Veronal Buffer — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
- Dade® Thrombin Reagent — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
- Dade® Thrombin Reagent — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Siemens Healthcare Diagnostics Products Ltd
Sources (1)
- FDA UDI 41c26780-e2c0-46c9-b2b0-b33b784f9a98 37 fields · synced May 30, 2026