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REF 905-917 ABL90 FLEX sBOX

FDA UDI

Class II (US FDA UDI)

by Radiometer Medical ApS

Identity

Trade Name
REF 905-917 ABL90 FLEX sBOX FDA UDI
Generic Name
Metabolic profile clinical chemistry analyser IVD FDA UDI
Device Name
Solution box for the ABL90 FLEX, SBOX FDA UDI
Model / Reference
905-917 FDA UDI
Description
Solution box for the ABL90 FLEX, SBOX FDA UDI

Identifiers

Catalog Number
905-917 FDA UDI
Primary DI / UDI-DI
05700699059178 FDA UDI
FDA Product Code
JGS FDA UDI
KHP FDA UDI
JIX FDA UDI
CHL FDA UDI
GHS FDA UDI
KQI FDA UDI
CEM FDA UDI
JJY FDA UDI
CGZ FDA UDI
JFP FDA UDI
MQM FDA UDI
CGA FDA UDI
GKR FDA UDI
GMDN Term
Metabolic profile clinical chemistry analyser IVD FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
862.1665 FDA UDI
862.1450 FDA UDI
862.1150 FDA UDI
862.1120 FDA UDI
864.7425 FDA UDI
864.7455 FDA UDI
862.1600 FDA UDI
862.1660 FDA UDI
862.1170 FDA UDI
862.1145 FDA UDI
862.1113 FDA UDI
862.1345 FDA UDI
864.5620 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

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

REF 905-917 ABL90 FLEX sBOX 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 62749892-c52c-4050-9809-8e898df802ac 36 fields · synced May 30, 2026