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Sercon

FDA UDI

Class I (US FDA UDI)

by Sercon Limited

Identity

Trade Name
Sercon FDA UDI
Generic Name
Mass spectrometry analyser IVD FDA UDI
Device Name
ABCA GAS ISOTOPE RATIO MASS SPECTROMETER SYSTEMS FDA UDI
Model / Reference
20602 FDA UDI
Description
ABCA GAS ISOTOPE RATIO MASS SPECTROMETER SYSTEMS FDA UDI

Identifiers

Primary DI / UDI-DI
05061024690009 FDA UDI
510(k) Number
K992163 FDA UDI
FDA Product Code
DOP FDA UDI
GMDN Term
Mass spectrometry analyser IVD FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
862.2860 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

Yes

FDA UDI

Category: Mass spectrometry analyser IVD

Sercon by Sercon Limited — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Mass spectrometry analyser IVD.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Sercon Limited

Sources (1)

  • FDA UDI 42b34bf3-60a0-41ea-951a-80f57f7b3aad 35 fields · synced Jun 8, 2026