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ADVIA® Chemistry CHE Cholinesterase Reagents

FDA UDI

Class I (US FDA UDI)

by Siemens Healthcare Diagnostics

Identity

Trade Name
ADVIA® Chemistry CHE Cholinesterase Reagents FDA UDI
Generic Name
Acetylcholinesterase IVD, kit, spectrophotometry FDA UDI
Device Name
PCHE - ADVIA Chem. - RGT - 4x234 tests FDA UDI
Model / Reference
10315176 FDA UDI
Description
PCHE - ADVIA Chem. - RGT - 4x234 tests FDA UDI

Identifiers

Catalog Number
1410545 FDA UDI
Primary DI / UDI-DI
00630414510149 FDA UDI
510(k) Number
K013750 FDA UDI
FDA Product Code
DIH FDA UDI
GMDN Term
Acetylcholinesterase IVD, kit, spectrophotometry FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
862.3240 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

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Acetylcholinesterase IVD, kit, spectrophotometry

ADVIA® Chemistry CHE Cholinesterase Reagents by Siemens Healthcare Diagnostics — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Acetylcholinesterase IVD, kit, spectrophotometry.

Cleared under the same submission

K013750 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Siemens Healthcare Diagnostics

Sources (1)

  • FDA UDI 3140cc7d-d82b-4b76-a58b-5c61f3736687 37 fields · synced Jun 6, 2026