← Back to catalogue

ESR-Auto Plus

FDA UDI

Class I (US FDA UDI)

by Streck

Identity

Trade Name
ESR-Auto Plus FDA UDI
Generic Name
Erthrocyte sedimentation rate (ESR) analyser IVD FDA UDI
Device Name
A 10-position automated sed-rate analyzer. FDA UDI
Model / Reference
506 FDA UDI
Description
A 10-position automated sed-rate analyzer. FDA UDI

Identifiers

Primary DI / UDI-DI
00844509002147 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

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Erthrocyte sedimentation rate (ESR) analyser IVD

ESR-Auto Plus by Streck — 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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Streck

Sources (1)

  • FDA UDI 1ac5a697-61f8-473c-b01b-10fdd2f69bb4 34 fields · synced May 30, 2026