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D3 Ultra

FDA UDI

Class I (US FDA UDI)

by Diagnostic Hybrids, Inc.

Identity

Trade Name
D3 Ultra FDA UDI
Generic Name
Respiratory syncytial virus (RSV) antigen IVD, kit, fluorescent immunoassay FDA UDI
Device Name
RSV DFA Reagent FDA UDI
Model / Reference
01-013302.V2 FDA UDI
Description
RSV DFA Reagent FDA UDI

Identifiers

Catalog Number
01-013302.V2 FDA UDI
Primary DI / UDI-DI
30014613330424 FDA UDI
FDA Product Code
GNW FDA UDI
GMDN Term
Respiratory syncytial virus (RSV) antigen IVD, kit, fluorescent immunoassay FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
866.3330 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

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Respiratory syncytial virus (RSV) antigen IVD, kit, fluorescent immunoassay

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

Similar devices

Also classified as Respiratory syncytial virus (RSV) 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 8ce73c72-3237-457e-adf3-7cee3e866f0c 35 fields · synced Jun 8, 2026