Identity
- Trade Name
- CELLSHEATH CCS FDA UDI
- Generic Name
- Buffered sample diluent IVD FDA UDI
- Device Name
- Concentrated diluent for use in hematology analyzers FDA UDI
- Model / Reference
- ZA900004 FDA UDI
- Description
- Concentrated diluent for use in hematology analyzers FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00664369000622 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
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
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 — 20 Liter FDA UDI
Category: Buffered sample diluent IVD
Cellsheath Ccs by Sysmex Corp. — Class I — 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
- 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 | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Sysmex Corp.
Sources (1)
- FDA UDI 5137ba37-a7c9-4cd7-9ff1-2dd2d79eea3f 36 fields · synced May 30, 2026