Identity
- Trade Name
- Procleix System Fluid Preservative FDA UDI
- Generic Name
- Buffered sample diluent IVD FDA UDI
- Device Name
- A buffered diluent solution intended to be used as a consumable reagent on-board an automated or semi-automated instrument during the processing, staining and/or testing of clinical laboratory specimens. FDA UDI
- Model / Reference
- Procleix System Fluid Preservative Kit FDA UDI
- Description
- A buffered diluent solution intended to be used as a consumable reagent on-board an automated or semi-automated instrument during the processing, staining and/or testing of clinical laboratory specimens. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00859882007412 FDA UDI
- GMDN Term
- Buffered sample diluent IVD FDA UDI
Classification
- 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
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
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
Yes
FDA UDI
Category: Buffered sample diluent IVD
Procleix System Fluid Preservative by Grifols Diagnostic Solutions Inc. — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Buffered sample diluent IVD.
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- Dimension® Sample Diluent — Siemens Healthcare Diagnostics · Class II
- IMMULITE®/IMMULITE® 1000 Systems DHS DHEASO4 Sample Diluent — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD · Class I
- 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
- IMMULITE®/IMMULITE® 1000 Systems PRG Progesterone Sample Diluent — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD · Class I
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 | N/A | Pending data |
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Manufacturer
- Manufacturer
- Grifols Diagnostic Solutions Inc.
Sources (1)
- FDA UDI f679a8ed-3251-4234-b28d-ca098b7296ae 33 fields · synced Jun 9, 2026