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IMMULITE® 2000 Systems Reaction Tubes

FDA UDI

Class I (US FDA UDI)

by Siemens Medical Solutions Diagnostics Limited

Identity

Trade Name
IMMULITE® 2000 Systems Reaction Tubes FDA UDI
Generic Name
General specimen container IVD, no additive/medium FDA UDI
Device Name
Gear Driven Reaction Tubes 1000 - IMMULITE - CONS - 1000 Pieces FDA UDI
Model / Reference
10385206 FDA UDI
Description
Gear Driven Reaction Tubes 1000 - IMMULITE - CONS - 1000 Pieces FDA UDI

Identifiers

Catalog Number
LRXT FDA UDI
Primary DI / UDI-DI
00630414954547 FDA UDI
FDA Product Code
JJE FDA UDI
GMDN Term
General specimen container IVD, no additive/medium FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
862.2160 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

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

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: General specimen container IVD, no additive/medium

IMMULITE® 2000 Systems Reaction Tubes by Siemens Medical Solutions Diagnostics Limited — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as General specimen container IVD, no additive/medium.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Siemens Medical Solutions Diagnostics Limited

Sources (1)

  • FDA UDI 3892056c-e895-4a01-9a33-79816e297178 35 fields · synced May 30, 2026