Identity
- Trade Name
- ESR-Chex FDA UDI
- Generic Name
- Erythrocyte sedimentation rate (ESR) IVD, control FDA UDI
- Device Name
- A two-level hematology control used to monitor erythrocyte sedimentation rates. Contains 4 vials each of level 1 & 2. FDA UDI
- Model / Reference
- 214108 FDA UDI
- Description
- A two-level hematology control used to monitor erythrocyte sedimentation rates. Contains 4 vials each of level 1 & 2. FDA UDI
Identifiers
- Catalog Number
- 214108 FDA UDI
- Primary DI / UDI-DI
- 00844509001645 FDA UDI
- FDA Product Code
- JPH FDA UDI
- GMDN Term
- Erythrocyte sedimentation rate (ESR) IVD, control FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 864.6700 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
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 — 9.0 Milliliter FDA UDI
Category: Erythrocyte sedimentation rate (ESR) IVD, control
ESR-Chex by Streck — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Erythrocyte sedimentation rate (ESR) IVD, control.
- ESR Control — DIESSE DIAGNOSTICA SENESE SPA · Class I
- HemaTechnologies ESR Control — Airscan, Inc. · Class II
- Research and Diagnostic Systems — RESEARCH AND DIAGNOSTIC SYSTEMS, INC. · Class II
- Accu-Sed® Plus Norm & Abn ESR Control Kit, 2x8.5mL — ELITECHGROUP INC. · Class I
- Research and Diagnostic Systems — RESEARCH AND DIAGNOSTIC SYSTEMS, INC. · Class II
- Starrsed Control — RR Mechatronics Manufacturing B.V. · Class I
- Research and Diagnostic Systems — RESEARCH AND DIAGNOSTIC SYSTEMS, INC. · Class II
- Accu-Sed® Plus Abnormal ESR Control Kit, 5x8.5mL — 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
- Streck
Sources (1)
- FDA UDI 4c770769-6e9b-4d4e-a617-c3ae48a4cc65 37 fields · synced May 30, 2026