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Abl800 Flex

FDA UDI

Class II (US FDA UDI)

by Radiometer Medical ApS

Identity

Trade Name
ABL800 FLEX FDA UDI
Generic Name
Multiple clinical chemistry analyser IVD, laboratory FDA UDI
Device Name
ABL800 FLEX with crea FDA UDI
Model / Reference
393-801 FDA UDI
Description
ABL800 FLEX with crea FDA UDI

Identifiers

Catalog Number
393-801 FDA UDI
Primary DI / UDI-DI
05700693938011 FDA UDI
FDA Product Code
CHL FDA UDI
CGA FDA UDI
CGL FDA UDI
CEM FDA UDI
KHP FDA UDI
JGS FDA UDI
MQM FDA UDI
KQI FDA UDI
CIG FDA UDI
CGZ FDA UDI
JFP FDA UDI
GHS FDA UDI
GMDN Term
Multiple clinical chemistry analyser IVD, laboratory FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
862.1120 FDA UDI
862.1345 FDA UDI
862.1225 FDA UDI
862.1600 FDA UDI
862.1450 FDA UDI
862.1665 FDA UDI
862.1113 FDA UDI
864.7455 FDA UDI
862.1110 FDA UDI
862.1170 FDA UDI
862.1145 FDA UDI
864.7425 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

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

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Multiple clinical chemistry analyser IVD, laboratory

Abl800 Flex by Radiometer Medical ApS — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Multiple clinical chemistry analyser IVD, laboratory.

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 cb64116c-4b51-469e-b0d9-94cb756723bd 36 fields · synced May 30, 2026