Identity
- Trade Name
- RET-SEARCH II FDA UDI
- Generic Name
- Reticulocyte count IVD, kit, cell count FDA UDI
- Device Name
- Diluent and dye for reticulocyte count with hematology analyzers. Reticulocyte test kit for determination of reticulocyte count and reticulocyte percent in human blood. Contents: RET-SEARCH (II) Diluent (RED-300) and RET-SEARCH (II) Dye (RED-800) FDA UDI
- Model / Reference
- RED-700A FDA UDI
- Description
- Diluent and dye for reticulocyte count with hematology analyzers. Reticulocyte test kit for determination of reticulocyte count and reticulocyte percent in human blood. Contents: RET-SEARCH (II) Diluent (RED-300) and RET-SEARCH (II) Dye (RED-800) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00664369201340 FDA UDI
- FDA Product Code
- GIF FDA UDI
- GMDN Term
- Reticulocyte count IVD, kit, cell count 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
Yes
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 — 1000 Milliliter FDA UDITotal Volume — 12 Milliliter FDA UDI
Category: Reticulocyte count IVD, kit, cell count
Ret-Search Ii by Sysmex Corp. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 a95d545e-40d1-4563-991b-a242f5c5ed1e 36 fields · synced May 30, 2026