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Diagnostix™

FDA UDI

Class I (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-X,Derm/Throat-X FDA UDI
Model / Reference
56802A-56X FDA UDI
Description
Adstation Oto+-L/Coax+Oph-X,Derm/Throat-X FDA UDI

Identifiers

Catalog Number
56802A-56X FDA UDI
Primary DI / UDI-DI
00634782088699 FDA UDI
FDA Product Code
ERA FDA UDI
HLJ FDA UDI
IBJ FDA UDI
GMDN Term
Ophthalmic/otologic diagnostic set FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
874.4770 FDA UDI
886.1570 FDA UDI
864.3600 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

Yes

FDA UDI

Convenience Kit

Yes

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

Yes

FDA UDI

Category: Ophthalmic/otologic diagnostic setDermatoscope, optical

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

Similar devices

Also classified as Dermatoscope, optical.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
American Diagnostic Corporation

Sources (1)

  • FDA UDI 07ba163a-4606-4933-a57c-ec1dcf29d91f 36 fields · synced May 30, 2026