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Zellesr-10

FDA UDI

Class I (US FDA UDI)

by Sterile Safequip & Chemicals Llp

Identity

Trade Name
ZELLESR-10 FDA UDI
Generic Name
Erthrocyte sedimentation rate (ESR) analyser IVD FDA UDI
Device Name
Semi Automatic ESR Analyzer FDA UDI
Model / Reference
11.ZE10 FDA UDI
Description
Semi Automatic ESR Analyzer FDA UDI

Identifiers

Catalog Number
ZE10 FDA UDI
Primary DI / UDI-DI
00860011967712 FDA UDI
FDA Product Code
JPH FDA UDI
GMDN Term
Erthrocyte sedimentation rate (ESR) analyser IVD FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
864.6700 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

Zellesr-10 by Sterile Safequip & Chemicals Llp — 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
Sterile Safequip & Chemicals Llp

Sources (1)

  • FDA UDI 09bd63e5-d7b8-4f7e-afa4-5e992272de71 34 fields · synced May 31, 2026