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D3

FDA UDI

Class I (US FDA UDI)

by Diagnostic Hybrids, Inc.

Identity

Trade Name
D3 FDA UDI
Generic Name
Multiple Chlamydia species antigen IVD, kit, fluorescent immunoassay FDA UDI
Device Name
D3 DFA CHLM CULT CONF KIT FDA UDI
Model / Reference
DFA Chlamydiae Kit FDA UDI
Description
D3 DFA CHLM CULT CONF KIT FDA UDI

Identifiers

Catalog Number
01-040000 FDA UDI
Primary DI / UDI-DI
30014613330547 FDA UDI
510(k) Number
K063675 FDA UDI
FDA Product Code
LJP FDA UDI
GMDN Term
Multiple Chlamydia species antigen IVD, kit, fluorescent immunoassay FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
866.3120 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

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

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Multiple Chlamydia species antigen IVD, kit, fluorescent immunoassay

D3 by Diagnostic Hybrids, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Multiple Chlamydia species antigen IVD, kit, fluorescent immunoassay.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Diagnostic Hybrids, Inc.

Sources (1)

  • FDA UDI eedb07d4-a93a-4162-8b2a-f2bfad19d1ee 36 fields · synced Jun 8, 2026