Emit II Plus Specialty Multi Drug Calibrator/Control Level 3

FDA UDIEUDAMED

Class I (US FDA UDI)

by Siemens Healthcare Diagnostics

Identity

Trade Name: Emit II Plus Specialty Multi Drug Calibrator/Control Level 3 FDA UDI
Generic Name: Multiple drugs of abuse IVD, calibrator FDA UDI
Device Name: Emit II Plus Specialty Multi Drug Calibrator/Control Level 3 FDA UDI
Model / Reference: 10720814 FDA UDI
Description: Emit II Plus Specialty Multi Drug Calibrator/Control Level 3 FDA UDI

Identifiers

Catalog Number: 9T569UL FDA UDI
Primary DI / UDI-DI: 00630414027951 FDA UDI
FDA Product Code: LAS FDA UDI
DLJ FDA UDI
GMDN Term: Multiple drugs of abuse IVD, calibrator FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 862.3280 FDA UDI
862.3200 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Multiple drugs of abuse IVD, calibrator

Emit II Plus Specialty Multi Drug Calibrator/Control Level 3 by Siemens Healthcare Diagnostics — Class I — IVDR, FDA UDI — listed in FDA GUDID, EUDAMED

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Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Unknown

IVDR

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
EUDAMED	European Union	IVDR	—	Class I	Unknown
FDA UDI	United States	FDA UDI	Registered in GUDID	Class I	Pending data

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Manufacturer

Manufacturer: Siemens Healthcare Diagnostics

Sources (2)

FDA UDI 028b28a5-25e1-4ab5-aace-03cbc4e6a6c0 36 fields · synced Jun 19, 2026
EUDAMED 1 fields · synced Jun 11, 2026