Syva® Emit® II Plus Methadone Assay

FDA UDIEUDAMED

Class II (US FDA UDI)

by Siemens Healthcare Diagnostics

Identity

Trade Name: Syva® Emit® II Plus Methadone Assay FDA UDI
Generic Name: Methadone IVD, kit, enzyme immunoassay (EIA) FDA UDI
Device Name: Syva® Emit® II Plus Methadone Assay - 1 L Kit FDA UDI
Model / Reference: 10445428 FDA UDI
Description: Syva® Emit® II Plus Methadone Assay - 1 L Kit FDA UDI

Identifiers

Catalog Number: 9E129UL FDA UDI
Primary DI / UDI-DI: 00842768000157 FDA UDI
510(k) Number: K994005 FDA UDI
FDA Product Code: DJR FDA UDI
GMDN Term: Methadone IVD, kit, enzyme immunoassay (EIA) FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 862.3620 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

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Methadone IVD, kit, enzyme immunoassay (EIA)

Syva® Emit® II Plus Methadone Assay by Siemens Healthcare Diagnostics — Class II — IVDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS

Similar devices

Also classified as Methadone IVD, kit, enzyme immunoassay (EIA).

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Pointe Methadone Reagent Set — POINTE SCIENTIFIC, INC. · Class II
CAROLINA LIQUID CHEMISTRIES CORP.® METD RGT. KIT ST415 — Carolina Liquid Chemistries Corp. · Class II
CAROLINA LIQUID CHEMISTRIES CORP.® METD RGT. KIT AU-415 — Carolina Liquid Chemistries Corp. · Class II
CAROLINA LIQUID CHEMISTRIES CORP.® METD RGT. KIT ST315 — Carolina Liquid Chemistries Corp. · Class II
VITROS — Ortho-Clinical Diagnostics · Class II
LZI Methadone II Enzyme Immunoassay — Lin-Zhi International, Inc. · Class II
Methadone Intercept 100 Plate Kit — OraSure Technologies, Inc. · Class II

Cleared under the same submission

K994005 also covers:

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 II	Unknown
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Siemens Healthcare Diagnostics

Sources (2)

FDA UDI 6d2d1041-6690-4927-a28d-d8763ba3b621 37 fields · synced Jun 19, 2026
EUDAMED 1 fields · synced Jun 19, 2026