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iSED Elite

FDA UDI

Class I (US FDA UDI)

by Alcor Scientific

Identity

Trade Name
iSED Elite FDA UDI
Generic Name
Erthrocyte sedimentation rate (ESR) analyser IVD FDA UDI
Device Name
Automated Erythrocyte Sedimentation Rate Analyzer FDA UDI
Model / Reference
112-00222 FDA UDI
Description
Automated Erythrocyte Sedimentation Rate Analyzer FDA UDI

Identifiers

Catalog Number
112-00222 FDA UDI
Primary DI / UDI-DI
00850028040041 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

iSED Elite by Alcor Scientific — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Erthrocyte sedimentation rate (ESR) analyser IVD.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Alcor Scientific

Sources (1)

  • FDA UDI c6710d03-89fb-460d-a0c2-f5cbe52c4a2e 34 fields · synced Jun 1, 2026