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ADVIA® Chemistry ISE Buffer

FDA UDI

Class I (US FDA UDI)

by Siemens Healthcare Diagnostics

Identity

Trade Name
ADVIA® Chemistry ISE Buffer FDA UDI
Generic Name
pH-adjusted buffer solution IVD FDA UDI
Device Name
ISE Buffer Large - ADVIA Chem. - CONS - 3 Liter FDA UDI
Model / Reference
10321715 FDA UDI
Description
ISE Buffer Large - ADVIA Chem. - CONS - 3 Liter FDA UDI

Identifiers

Catalog Number
4997873 FDA UDI
Primary DI / UDI-DI
00630414526768 FDA UDI
FDA Product Code
JCC FDA UDI
GMDN Term
pH-adjusted buffer solution IVD FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
864.4010 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

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: pH-adjusted buffer solution IVD

ADVIA® Chemistry ISE Buffer by Siemens Healthcare Diagnostics — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as pH-adjusted buffer solution IVD.

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 7e78f691-e52f-4b34-be98-a56539040607 35 fields · synced Jun 8, 2026