Identity
- Trade Name
- Research and Diagnostic Systems FDA UDI
- Generic Name
- Erythrocyte sedimentation rate (ESR) IVD, control FDA UDI
- Device Name
- SedRite III: 8 x 9mL (4 each Level 1,2) FDA UDI
- Model / Reference
- SED004 FDA UDI
- Description
- SedRite III: 8 x 9mL (4 each Level 1,2) FDA UDI
Identifiers
- Catalog Number
- SED004 FDA UDI
- Primary DI / UDI-DI
- 00815762021343 FDA UDI
- 510(k) Number
- K991876 FDA UDI
- FDA Product Code
- JPK FDA UDI
- GMDN Term
- Erythrocyte sedimentation rate (ESR) IVD, control FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 864.8625 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
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
No
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 — 72 Milliliter FDA UDI
Category: Erythrocyte sedimentation rate (ESR) IVD, control
Research and Diagnostic Systems by Research And Diagnostic Systems, Inc. — Class II — 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
- ESR-Chex — Streck · Class I
- Accu-Sed® Plus Norm & Abn ESR Control Kit, 2x8.5mL — ELITECHGROUP INC. · Class I
- Starrsed Control — RR Mechatronics Manufacturing B.V. · Class I
- ESR-Chex — Streck · Class I
- ESR-Chex — Streck · Class I
- ESR-Chex — Streck · Class I
Cleared under the same submission
K991876 also covers:
- HemaTechnologies ESR Control — Airscan, Inc.
- HemaTechnologies ESR Control — Airscan, Inc.
- HemaTechnologies ESR Control — Airscan, Inc.
- HemaTechnologies ESR Control — Airscan, Inc.
- Research and Diagnostic Systems — RESEARCH AND DIAGNOSTIC SYSTEMS, INC.
- Research and Diagnostic Systems — RESEARCH AND DIAGNOSTIC SYSTEMS, INC.
- Research and Diagnostic Systems — RESEARCH AND DIAGNOSTIC SYSTEMS, INC.
- Research and Diagnostic Systems — RESEARCH AND DIAGNOSTIC SYSTEMS, INC.
- Research and Diagnostic Systems — RESEARCH AND DIAGNOSTIC SYSTEMS, INC.
- Research and Diagnostic Systems — RESEARCH AND DIAGNOSTIC SYSTEMS, INC.
- Research and Diagnostic Systems — RESEARCH AND DIAGNOSTIC SYSTEMS, INC.
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 II | Pending data |
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Manufacturer
- Manufacturer
- Research And Diagnostic Systems, Inc.
Sources (1)
- FDA UDI dd02c8bf-7b6a-4f10-ae98-61f99ffc7ac8 38 fields · synced May 30, 2026