ADVIA® Chemistry Alkaline Phosphatase (ALP_2c) Reagents

FDA UDI

Class II (US FDA UDI)

by Siemens Healthcare Diagnostics

Identity

Trade Name: ADVIA® Chemistry Alkaline Phosphatase (ALP_2c) Reagents FDA UDI
Generic Name: Alanine aminotransferase (ALT) IVD, reagent FDA UDI
Device Name: Alkaline Phosphatase - ADVIA Chem. - Conc. RGT - 6x1240 FDA UDI
Model / Reference: 10916067 FDA UDI
Description: Alkaline Phosphatase - ADVIA Chem. - Conc. RGT - 6x1240 FDA UDI

Identifiers

Catalog Number: 10916067 FDA UDI
Primary DI / UDI-DI: 00630414600611 FDA UDI
510(k) Number: K121907 FDA UDI
FDA Product Code: CJO FDA UDI
GMDN Term: Alanine aminotransferase (ALT) IVD, reagent FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 862.1050 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: Alanine aminotransferase (ALT) IVD, reagent

ADVIA® Chemistry Alkaline Phosphatase (ALP_2c) Reagents by Siemens Healthcare Diagnostics — Class II — FDA UDI — listed in FDA GUDID

Similar devices

Also classified as Alanine aminotransferase (ALT) IVD, reagent.

ALT (SGPT) LIQUID REAGENT (KINETIC METHOD) — TECO DIAGNOSTICS · Class I
GPT LIQUID R1:4x36, R2:2x18 ml (GSAU) — Biotechnological Applications Ltd · IVD General
BIOBASE — Biobase Biodustry(Shandong)Co., Ltd. · Class I
BIOBASE — Biobase Biodustry(Shandong)Co., Ltd. · Class I
Synermed® — INFRARED LABORATORY SYSTEMS LLC · Class I
ALANINE AMINOTRANSFERASE LIQUID KIT（IFCC METHOD） — DIRUI INDUSTRIAL CO., LTD · IVD General
Alanine aminotransferase (ALT/GPT) - Liquizyme (4+1) — Egyptian Company For Biotechnology-Spectrum Diagnostics · IVD General
Alinity — Abbott · Class I

Cleared under the same submission

K121907 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Siemens Healthcare Diagnostics

Sources (1)

FDA UDI 1b376fe8-c6f0-4e77-b327-eed1000c581b 37 fields · synced May 30, 2026