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Synovasure®

FDA UDI

Class II (US FDA UDI)

by Cd Diagnostics, Inc.

Identity

Trade Name
Synovasure® FDA UDI
Generic Name
Alpha defensin IVD, kit, rapid ICT, clinical FDA UDI
Model / Reference
00-8888-125-10 FDA UDI

Identifiers

Catalog Number
00-8888-125-10 FDA UDI
Primary DI / UDI-DI
00887868358838 FDA UDI
510(k) Number
DEN180032 FDA UDI
FDA Product Code
QGN FDA UDI
GMDN Term
Alpha defensin IVD, kit, rapid ICT, clinical FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
866.3230 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

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

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Alpha defensin IVD, kit, rapid ICT, clinical

Synovasure® by Cd Diagnostics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Alpha defensin IVD, kit, rapid ICT, clinical.

Cleared under the same submission

DEN180032 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Cd Diagnostics, Inc.

Sources (1)

  • FDA UDI db60556f-c9f1-4c92-85c1-f3a884dcc9f7 35 fields · synced Jun 8, 2026