NOVA Lite® ANCA (Ethanol) Kit with DAPI

FDA UDI

Class II (US FDA UDI)

by Inova Diagnostics, Inc.

Identity

Trade Name: NOVA Lite® ANCA (Ethanol) Kit with DAPI FDA UDI
Generic Name: Multiple anti-neutrophil cytoplasmic antibody (ANCA) IVD, kit, fluorescent immunoassay FDA UDI
Device Name: 1. 20x ANCA (Ethanol Fixed Human Neutrophil), slides - 12 wells 2. 1x 15mL FITC IgG Conjugate with DAPI 3. 1x 0.5 mL cANCA Positive 4. 1x 0.5 mL pANCA Positive 5. 1x 0.5mL IFA System Negative Control 6. 2x 25mL PBS II Concentrate (40x) 7. 1x 7mL Mounting Medium 8. 1x 20 Coverslips 9. 1x Direction Insert FDA UDI
Model / Reference: 708301 FDA UDI
Description: 1. 20x ANCA (Ethanol Fixed Human Neutrophil), slides - 12 wells 2. 1x 15mL FITC IgG Conjugate with DAPI 3. 1x 0.5 mL cANCA Positive 4. 1x 0.5 mL pANCA Positive 5. 1x 0.5mL IFA System Negative Control 6. 2x 25mL PBS II Concentrate (40x) 7. 1x 7mL Mounting Medium 8. 1x 20 Coverslips 9. 1x Direction Insert FDA UDI

Identifiers

Primary DI / UDI-DI: 08426950602125 FDA UDI
510(k) Number: K961340 FDA UDI
FDA Product Code: MOB FDA UDI
GMDN Term: Multiple anti-neutrophil cytoplasmic antibody (ANCA) IVD, kit, fluorescent immunoassay FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 866.5660 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® ANCA (Ethanol) Kit with DAPI by Inova Diagnostics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K961340 also covers:

NOVA Lite® ANCA Kit — 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 c02f2fa2-0c9c-457a-b765-f094cb0af82e 37 fields · synced Jun 6, 2026