Identity
- Trade Name
- Monosed® ESR Vacuum Tubes FDA UDI
- Generic Name
- Evacuated erythrocyte sedimentation rate (ESR) tube IVD FDA UDI
- Device Name
- ESR Tubes are single use devices intended to be used as whole blood sample tubes for the quantitative determination of Erythrocyte Sedimentation Rate (ESR) using ELITechGroup ESR analyzers. These devices are to be used by trained medical personnel only. The ESR tubes are intended for IN VITRO DIAGNOSTIC USE ONLY (IVD). FDA UDI
- Model / Reference
- PRD-PRV11B-50 FDA UDI
- Description
- ESR Tubes are single use devices intended to be used as whole blood sample tubes for the quantitative determination of Erythrocyte Sedimentation Rate (ESR) using ELITechGroup ESR analyzers. These devices are to be used by trained medical personnel only. The ESR tubes are intended for IN VITRO DIAGNOSTIC USE ONLY (IVD). FDA UDI
Identifiers
- Catalog Number
- PRD-PRV11B-50 FDA UDI
- Primary DI / UDI-DI
- 03661540300202 FDA UDI
- FDA Product Code
- GKB FDA UDI
- GMDN Term
- Evacuated erythrocyte sedimentation rate (ESR) tube 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
Yes
FDA UDI
Single Use
Yes
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Evacuated erythrocyte sedimentation rate (ESR) tube IVD
Monosed® ESR Vacuum Tubes by Elitechgroup Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Evacuated erythrocyte sedimentation rate (ESR) tube IVD.
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- S-Sedivette® — Sarstedt Aktiengesellschaft & Co.KG · Class II
- Excyte® ESR Vacuum Tubes, Carton — ELITECHGROUP INC. · 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 679cc166-b022-4756-97ee-1513021d49a3 35 fields · synced May 30, 2026