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ADVIA Chemistry P5PL_c Reagent

FDA UDI

Class II (US FDA UDI)

by Siemens Healthcare Diagnostics

Identity

Trade Name
ADVIA Chemistry P5PL_c Reagent FDA UDI
Generic Name
Multiple clinical chemistry enzyme IVD, reagent FDA UDI
Device Name
ADVIA Chemistry Liquid P5P for use with ALTPLc and ASTPLc FDA UDI
Model / Reference
10729782 FDA UDI
Description
ADVIA Chemistry Liquid P5P for use with ALTPLc and ASTPLc FDA UDI

Identifiers

Catalog Number
10729782 FDA UDI
Primary DI / UDI-DI
00630414008950 FDA UDI
FDA Product Code
CIT FDA UDI
CKA FDA UDI
GMDN Term
Multiple clinical chemistry enzyme IVD, reagent FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
862.1100 FDA UDI
862.1030 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

Yes

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

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Multiple clinical chemistry enzyme IVD, reagent

ADVIA Chemistry P5PL_c Reagent by Siemens Healthcare Diagnostics — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Multiple clinical chemistry enzyme IVD, reagent.

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 7db792dd-055f-49ef-8a5d-d542c4bf00d5 36 fields · synced May 30, 2026