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D3 Fastpoint

FDA UDI

Class I (US FDA UDI)

by Diagnostic Hybrids, Inc.

Identity

Trade Name
D3 Fastpoint FDA UDI
Generic Name
Multiple-genus respiratory virus antigen IVD, kit, fluorescent immunoassay FDA UDI
Device Name
D3 FASTPOINT LDFA VIR IDKIT BX FDA UDI
Model / Reference
01-120000.B1 FDA UDI
Description
D3 FASTPOINT LDFA VIR IDKIT BX FDA UDI

Identifiers

Catalog Number
01-120000.B1 FDA UDI
Primary DI / UDI-DI
30014613330769 FDA UDI
FDA Product Code
GQS FDA UDI
OMG FDA UDI
GNS FDA UDI
LKT FDA UDI
GNY FDA UDI
GMDN Term
Multiple-genus respiratory virus antigen IVD, kit, fluorescent immunoassay FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
866.3400 FDA UDI
866.3980 FDA UDI
866.3330 FDA UDI
866.3480 FDA UDI
866.3020 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-genus respiratory virus antigen IVD, kit, fluorescent immunoassay

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

Similar devices

Also classified as Multiple-genus respiratory virus 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 af124d63-dbd3-45ea-bc6e-d00689a74cb0 35 fields · synced May 30, 2026