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Test1 Thl

FDA UDI

Class I (US FDA UDI)

by Alifax Srl

Identity

Trade Name
TEST1 THL FDA UDI
Generic Name
Erthrocyte sedimentation rate (ESR) analyser IVD FDA UDI
Device Name
TEST-1 THL - ESR automated analyzer, with Software for Latex Controls. Using different CBC rack metal adaptors. FDA UDI
Model / Reference
TEST1 THL FDA UDI
Description
TEST-1 THL - ESR automated analyzer, with Software for Latex Controls. Using different CBC rack metal adaptors. FDA UDI

Identifiers

Catalog Number
SI 195.210/THL FDA UDI
Primary DI / UDI-DI
08056040141519 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

Test1 Thl by Alifax Srl — 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
Alifax Srl

Sources (1)

  • FDA UDI b96403c3-cfa1-414f-b73d-72f6e95e38be 35 fields · synced Jun 8, 2026