Identity
- Trade Name
- Microsed-System® Automated ESR Analyzer FDA UDI
- Generic Name
- Erthrocyte sedimentation rate (ESR) analyser IVD FDA UDI
- Device Name
- The ESR analyzer is an automated, microprocessor controlled, in vitro diagnostic device that is intended for the quantitative determination of erythrocyte sedimentation rate (ESR) in human whole blood samples by laboratory professionals. Elevated ESR results indicate degrees of inflammation or disease present in the human body. FDA UDI
- Model / Reference
- PRD-MSS-EL-08TKNE FDA UDI
- Description
- The ESR analyzer is an automated, microprocessor controlled, in vitro diagnostic device that is intended for the quantitative determination of erythrocyte sedimentation rate (ESR) in human whole blood samples by laboratory professionals. Elevated ESR results indicate degrees of inflammation or disease present in the human body. FDA UDI
Identifiers
- Catalog Number
- PRD-MSS-EL-08TKNE FDA UDI
- Primary DI / UDI-DI
- 03661540300035 FDA UDI
- FDA Product Code
- GKB FDA UDI
- GMDN Term
- Erthrocyte sedimentation rate (ESR) analyser IVD FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 864.5800 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
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Erthrocyte sedimentation rate (ESR) analyser IVD
Microsed-System® Automated ESR Analyzer by Elitechgroup Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Erthrocyte sedimentation rate (ESR) analyser IVD.
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- ESR STAT 6 — Airscan, Inc. · Class I
- ESR-Auto Plus — Streck · Class I
- ROLLER 10 PLUS NEEDLE — ALIFAX SRL · 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
- Elitechgroup Inc.
Sources (1)
- FDA UDI 2e57dda3-b80a-4fd9-b7c8-c27cffc54cc3 35 fields · synced May 30, 2026