← Back to catalogue

ADVIA® 120/2120/2120i 3-in-1 TESTpoint Low Control

FDA UDI

Class II (US FDA UDI)

by Siemens Healthcare Diagnostics

Identity

Trade Name
ADVIA® 120/2120/2120i 3-in-1 TESTpoint Low Control FDA UDI
Generic Name
Full blood count IVD, control FDA UDI
Device Name
ADVIA®120/2120/2120i 3 in 1 TESTpoint™ Low Control FDA UDI
Model / Reference
10330063 FDA UDI
Description
ADVIA®120/2120/2120i 3 in 1 TESTpoint™ Low Control FDA UDI

Identifiers

Catalog Number
T03-4417-54 FDA UDI
Primary DI / UDI-DI
00630414473406 FDA UDI
510(k) Number
K993825 FDA UDI
FDA Product Code
JCN FDA UDI
GMDN Term
Full blood count IVD, control FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
864.8625 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: Full blood count IVD, control

ADVIA® 120/2120/2120i 3-in-1 TESTpoint Low Control by Siemens Healthcare Diagnostics — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Full blood count IVD, control.

Cleared under the same submission

K993825 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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

Manufacturer

Manufacturer
Siemens Healthcare Diagnostics

Sources (1)

  • FDA UDI b3699e5c-7569-4f0f-bd8d-7d8864a3f2da 37 fields · synced May 30, 2026