Identity
- Trade Name
- PHOENIX DIAGNOSTICS, INC. FDA UDI
- Generic Name
- Buffered sample diluent IVD FDA UDI
- Device Name
- ISE Diluent for Roche / Hitachi 700 & 900 Series Chemistry Systems FDA UDI
- Model / Reference
- 16-201 FDA UDI
- Description
- ISE Diluent for Roche / Hitachi 700 & 900 Series Chemistry Systems FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00853366007158 FDA UDI
- 510(k) Number
- K013451 FDA UDI
- FDA Product Code
- PPM FDA UDI
- GMDN Term
- Buffered sample diluent IVD FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 864.4010 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
Phoenix Diagnostics, Inc. by Phoenix Diagnostics, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Buffered sample diluent IVD.
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- IMMULITE®/IMMULITE® 1000 Systems PRG Progesterone Sample Diluent — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD · Class I
Cleared under the same submission
K013451 also covers:
- PHOENIX DIAGNOSTICS, INC. — PHOENIX DIAGNOSTICS, INC.
- PHOENIX DIAGNOSTICS, INC. — PHOENIX DIAGNOSTICS, INC.
- PHOENIX DIAGNOSTICS, INC. — PHOENIX DIAGNOSTICS, INC.
- PHOENIX DIAGNOSTICS, INC. — PHOENIX DIAGNOSTICS, INC.
- PHOENIX DIAGNOSTICS, INC. — PHOENIX DIAGNOSTICS, INC.
- PHOENIX DIAGNOSTICS, INC. — PHOENIX DIAGNOSTICS, INC.
- PHOENIX DIAGNOSTICS, INC. — PHOENIX DIAGNOSTICS, INC.
- PHOENIX DIAGNOSTICS, INC. — PHOENIX DIAGNOSTICS, INC.
- PHOENIX DIAGNOSTICS, INC. — PHOENIX DIAGNOSTICS, INC.
- Phoenix Diagnostics — PHOENIX DIAGNOSTICS, INC.
- Phoenix Diagnostics — PHOENIX DIAGNOSTICS, INC.
- Phoenix Diagnostics — PHOENIX DIAGNOSTICS, 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 I | Pending data |
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Manufacturer
- Manufacturer
- Phoenix Diagnostics, Inc.
Sources (1)
- FDA UDI 12b2eb0a-9b04-4015-9dfd-22b967fe9142 34 fields · synced Jun 1, 2026