Identity
- Trade Name
- Diagnostix™ FDA UDI
- Generic Name
- Ophthalmic/otologic diagnostic set FDA UDI
- Device Name
- Adstation Oto-X/Coax+Oph-X,429, 9005W/Spec Disp, WB FDA UDI
- Model / Reference
- 56102X-349W FDA UDI
- Description
- Adstation Oto-X/Coax+Oph-X,429, 9005W/Spec Disp, WB FDA UDI
Identifiers
- Catalog Number
- 56102X-349W FDA UDI
- Primary DI / UDI-DI
- 00634782087821 FDA UDI
- FDA Product Code
- FLL FDA UDIERA FDA UDIHLJ FDA UDI
- GMDN Term
- Ophthalmic/otologic diagnostic set FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.2910 FDA UDI874.4770 FDA UDI886.1570 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 setInfrared patient thermometer, skin
Diagnostix™ by American Diagnostic Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K081160 also covers:
- 1byone — 1BYONEPRODUCTS INC.
- Adtemp™ — American Diagnostic Corporation
- Diagnostix. — American Diagnostic Corporation
- Diagnostix™ — American Diagnostic Corporation
- Diagnostix™ — American Diagnostic Corporation
- Diagnostix™ — American Diagnostic Corporation
- Diagnostix™ — American Diagnostic Corporation
- Diagnostix™ — American Diagnostic Corporation
- Diagnostix™ — American Diagnostic Corporation
- Diagnostix™ — American Diagnostic Corporation
- Diagnostix™ — American Diagnostic Corporation
- Diagnostix™ — American Diagnostic Corporation
K950914 also covers:
- Adstation™ — American Diagnostic Corporation
- Adstation™ — American Diagnostic Corporation
- Adstation™ — American Diagnostic Corporation
- Adstation™ — American Diagnostic Corporation
- Adstation™ — American Diagnostic Corporation
- Adstation™ — American Diagnostic Corporation
- Adstation™ — American Diagnostic Corporation
- Adstation™ — American Diagnostic Corporation
- Adstation™ — American Diagnostic Corporation
- Adstation™ — American Diagnostic Corporation
- Adstation™ — American Diagnostic Corporation
- Adstation™ — American Diagnostic Corporation
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 28a0a36a-9db5-4c14-b5ba-416903b0598e 37 fields · synced May 31, 2026