Diagnostix™

FDA UDI

Class II (US FDA UDI)

by American Diagnostic Corporation

Identity

Trade Name: Diagnostix™ FDA UDI
Generic Name: Ophthalmic/otologic diagnostic set FDA UDI
Device Name: Adstation Oto+-L/Coax Oph-L,429, Clock Aner/Spec Disp, WB FDA UDI
Model / Reference: 5680L-347W FDA UDI
Description: Adstation Oto+-L/Coax Oph-L,429, Clock Aner/Spec Disp, WB FDA UDI

Identifiers

Catalog Number: 5680L-347W FDA UDI
Primary DI / UDI-DI: 00634782091385 FDA UDI
FDA Product Code: HLJ FDA UDI
ERA FDA UDI
FLL FDA UDI
DXQ FDA UDI
GMDN Term: Ophthalmic/otologic diagnostic set FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 886.1570 FDA UDI
874.4770 FDA UDI
880.2910 FDA UDI
870.1120 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

Yes

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Aneroid manual sphygmomanometer Ophthalmic/otologic diagnostic set Infrared patient thermometer, skin

Diagnostix™ by American Diagnostic Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: American Diagnostic Corporation

Sources (1)

FDA UDI ca3cc1ff-cd76-44ac-b747-aca07a03a7bf 36 fields · synced Jun 8, 2026