Identity
- Trade Name
- XW pack D FDA UDI
- Generic Name
- Buffered sample diluent IVD FDA UDI
- Device Name
- XW pack D is a proprietary reagent which is used to blank the system, dilute the whole blood sample prior to analysis and rinse the analyzed sample out of the system post analysis. FDA UDI
- Model / Reference
- ZA900005 FDA UDI
- Description
- XW pack D is a proprietary reagent which is used to blank the system, dilute the whole blood sample prior to analysis and rinse the analyzed sample out of the system post analysis. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10664369000643 FDA UDI
- FDA Product Code
- GIF FDA UDI
- GMDN Term
- Buffered sample diluent IVD FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 864.8200 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
Yes
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
Yes
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 — 2 Liter FDA UDI
Category: Buffered sample diluent IVD
XW pack D by Sysmex Corp. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- Lumipulse G Specimen Diluent 2 — FUJIREBIO INC. · Class I
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- 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 | Class I | Pending data |
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Manufacturer
- Manufacturer
- Sysmex Corp.
Sources (1)
- FDA UDI 18d6057d-1443-415f-8d22-74388560849e 36 fields · synced May 30, 2026