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ADVIA® Chemistry PREALB Prealbumin Reagents

FDA UDI

Class I (US FDA UDI)

by Siemens Healthcare Diagnostics

Identity

Trade Name
ADVIA® Chemistry PREALB Prealbumin Reagents FDA UDI
Generic Name
Prealbumin (transthyretin) IVD, kit, nephelometry/turbidimetry FDA UDI
Device Name
Pre-Albumin - ADVIA Chem. - RGT - 2x100 tests FDA UDI
Model / Reference
10318214 FDA UDI
Description
Pre-Albumin - ADVIA Chem. - RGT - 2x100 tests FDA UDI

Identifiers

Catalog Number
3057680 FDA UDI
Primary DI / UDI-DI
00630414517704 FDA UDI
510(k) Number
K000661 FDA UDI
FDA Product Code
JZJ FDA UDI
GMDN Term
Prealbumin (transthyretin) IVD, kit, nephelometry/turbidimetry FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
866.5060 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: Prealbumin (transthyretin) IVD, kit, nephelometry/turbidimetry

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

Similar devices

Also classified as Prealbumin (transthyretin) IVD, kit, nephelometry/turbidimetry.

Cleared under the same submission

K000661 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 7e4b1f69-9187-4d94-bc6a-93e5e2d05533 37 fields · synced May 29, 2026