NOVA Lite® dsDNA Crithidia Luciliae Kit with DAPI

FDA UDI

Class II (US FDA UDI)

by Inova Diagnostics, Inc.

Identity

Trade Name: NOVA Lite® dsDNA Crithidia Luciliae Kit with DAPI FDA UDI
Generic Name: Double stranded DNA antibody (anti-dsDNA) IVD, kit, fluorescent immunoassay FDA UDI
Device Name: 1. 20x 12-well bar-coded dsDNA Crithidia luciliae Substrate Slides 2. 1x 15mL FITC Anti Human IgG Conjugate with DAPI 3. 1x 0.5 mL dsDNA Positive Control 4. 1x 0.5mL IFA System Negative Control 5. 2x 25mL PBS II Concentrate (40x) 6. 1x 7mL Mounting Medium 7. 1x 20 Coverslips FDA UDI
Model / Reference: 708210 FDA UDI
Description: 1. 20x 12-well bar-coded dsDNA Crithidia luciliae Substrate Slides 2. 1x 15mL FITC Anti Human IgG Conjugate with DAPI 3. 1x 0.5 mL dsDNA Positive Control 4. 1x 0.5mL IFA System Negative Control 5. 2x 25mL PBS II Concentrate (40x) 6. 1x 7mL Mounting Medium 7. 1x 20 Coverslips FDA UDI

Identifiers

Primary DI / UDI-DI: 08426950631019 FDA UDI
510(k) Number: K880742 FDA UDI
FDA Product Code: DHN FDA UDI
GMDN Term: Double stranded DNA antibody (anti-dsDNA) IVD, kit, fluorescent immunoassay FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 866.5100 FDA UDI
Commercial Distribution: Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

NOVA Lite® dsDNA Crithidia Luciliae Kit with DAPI by Inova Diagnostics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K880742 also covers:

NOVA Lite® dsDNA Crithidia Luciliae — INOVA DIAGNOSTICS, INC.

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: Inova Diagnostics, Inc.

Sources (1)

FDA UDI 42cfac6c-ef23-4ee4-bb2a-193d75a36eb4 37 fields · synced Jun 8, 2026