Identity
- Trade Name
- ESR STAT 6 FDA UDI
- Generic Name
- Erthrocyte sedimentation rate (ESR) analyser IVD FDA UDI
- Model / Reference
- ESR STAT 6 FDA UDI
Identifiers
- Catalog Number
- ESR STAT 6 FDA UDI
- Primary DI / UDI-DI
- 00868556000208 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
No
FDA UDI
Category: Erthrocyte sedimentation rate (ESR) analyser IVD
Esr Stat 6 by Airscan, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Erthrocyte sedimentation rate (ESR) analyser IVD.
- Starrsed — MECHATRONICS USA · Class I
- Starrsed — MECHATRONICS USA · Class I
- JO-PLUS — ALIFAX SRL · Class I
- VISION ESR Analyzer — Shenzhen YHLO Biotech Co., Ltd. · Class I
- VISION ESR Analyzer — Shenzhen YHLO Biotech Co., Ltd. · Class I
- ESR-Auto Plus — Streck · Class I
- ROLLER 10 PLUS NEEDLE — ALIFAX SRL · Class I
- TEST1 2.0 — 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Airscan, Inc.
Sources (1)
- FDA UDI 262868fa-437f-4726-9d7d-0161f6d8c925 33 fields · synced Jun 6, 2026