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ESR-10 Manual Rack

FDA UDI

Class I (US FDA UDI)

by Streck

Identity

Trade Name
ESR-10 Manual Rack FDA UDI
Generic Name
Erythrocyte sedimentation rate (ESR) rack IVD, scaled measure FDA UDI
Device Name
A 10-position manual Modified Westergren system used for determining the erythrocyte sedimentation rate (ESR) of whole blood in 30 minutes using 1.2ml Streck ESR-Vacuum Tubes. FDA UDI
Model / Reference
240321 FDA UDI
Description
A 10-position manual Modified Westergren system used for determining the erythrocyte sedimentation rate (ESR) of whole blood in 30 minutes using 1.2ml Streck ESR-Vacuum Tubes. FDA UDI

Identifiers

Catalog Number
240321 FDA UDI
Primary DI / UDI-DI
00844509002123 FDA UDI
FDA Product Code
GKB FDA UDI
GMDN Term
Erythrocyte sedimentation rate (ESR) rack IVD, scaled measure 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: Erythrocyte sedimentation rate (ESR) rack IVD, scaled measure

ESR-10 Manual Rack by Streck — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Erythrocyte sedimentation rate (ESR) rack IVD, scaled measure.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Streck

Sources (1)

  • FDA UDI 8875c98a-9037-489d-b3d2-91b2a08459ac 35 fields · synced May 30, 2026