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ABL80 FLEX Analyzer

FDA UDI

Class II (US FDA UDI)

by Radiometer Medical ApS

Identity

Trade Name
ABL80 FLEX Analyzer FDA UDI
Generic Name
Metabolic profile clinical chemistry analyser IVD FDA UDI
Device Name
ABL80 FLEX Full panel, Analyzer FDA UDI
Model / Reference
393-839 FDA UDI
Description
ABL80 FLEX Full panel, Analyzer FDA UDI

Identifiers

Catalog Number
393-839 FDA UDI
Primary DI / UDI-DI
05700693938394 FDA UDI
FDA Product Code
CHL FDA UDI
GKR FDA UDI
GHS FDA UDI
CGZ FDA UDI
DQA FDA UDI
CEM FDA UDI
CGA FDA UDI
JJY FDA UDI
JPI FDA UDI
JGS FDA UDI
JFP FDA UDI
JIX FDA UDI
GMDN Term
Metabolic profile clinical chemistry analyser IVD FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
862.1120 FDA UDI
864.5620 FDA UDI
864.7425 FDA UDI
862.1170 FDA UDI
870.2700 FDA UDI
862.1600 FDA UDI
862.1345 FDA UDI
862.1660 FDA UDI
864.6400 FDA UDI
862.1665 FDA UDI
862.1145 FDA UDI
862.1150 FDA UDI
Commercial Distribution
Not 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

Yes

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

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

ABL80 FLEX Analyzer by Radiometer Medical ApS — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Radiometer Medical ApS

Sources (1)

  • FDA UDI 9864d2f6-eda4-415e-8462-8b05d404db00 37 fields · synced May 30, 2026