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NOVA Lite

EUDAMEDFDA UDI

Class IVD General (EU MDR)

Ref 704265Ref 708299Ref 704180

by Inova Diagnostics. Inc.

Identity

Trade Name
NOVA Lite EUDAMED
NOVA Lite®Rat Liver , Kidney, Stomach Kit FDA UDI
NOVA Lite® ANCA Kit FDA UDI
Generic Name
Intrinsic factor/parietal cell antibody IVD, kit, fluorescent immunoassay FDA UDI
Multiple anti-neutrophil cytoplasmic antibody (ANCA) IVD, kit, fluorescent immunoassay FDA UDI
Device Name
NOVA Lite® DAPI EMA Kit EUDAMED
NOVA Lite® ANCA Kit EUDAMED
NOVA Lite® Rat Liver, Kidney, Stomach Kit EUDAMED
1. 25 x Rat liver, kidney, stomach slide (10-well) 2. 1 x 1mL ANA Homogeneous Pattern (prediluted) 3. 1 x 1mL IFA System Negative Control (prediluted) 4. 1 x 1mL Mitochondrial (AMA) Pattern (prediluted) 5. 1 x 1mL Smooth Muscle (ASMA) Pattern (prediluted) 6. 1 x 15mL FITC IgG (H&L) Conjugate 7. 1 x 3mL 1% Evans Blue Counterstain 8. 2 x 25 PBS II Buffer (x40 conc) 9. 1 x 10mL Mounting Medium 10. 50 x Blotters 11. 25 x Coverslips 12. 1 x instruction leaflet FDA UDI
1. 10x 6-well ANCA ethanol-fixed human neutrophil substrate slides 2. 1x 4mL FITC Anti Human IgG Conjugate 3. 1x 0.5 mL cANCA Positive 4. 1x 0.5 mL pANCA Positive 5. 1x 0.5mL IFA System Negative Control 6. 1x 25mL PBS II Concentrate (40x) 7. 1x 7mL Mounting Medium 8. 1x 10 Coverslips FDA UDI
Model / Reference
704265 EUDAMED
708299 EUDAMEDFDA UDI
704180 EUDAMEDFDA UDI
Description
1. 25 x Rat liver, kidney, stomach slide (10-well) 2. 1 x 1mL ANA Homogeneous Pattern (prediluted) 3. 1 x 1mL IFA System Negative Control (prediluted) 4. 1 x 1mL Mitochondrial (AMA) Pattern (prediluted) 5. 1 x 1mL Smooth Muscle (ASMA) Pattern (prediluted) 6. 1 x 15mL FITC IgG (H&L) Conjugate 7. 1 x 3mL 1% Evans Blue Counterstain 8. 2 x 25 PBS II Buffer (x40 conc) 9. 1 x 10mL Mounting Medium 10. 50 x Blotters 11. 25 x Coverslips 12. 1 x instruction leaflet FDA UDI
1. 10x 6-well ANCA ethanol-fixed human neutrophil substrate slides 2. 1x 4mL FITC Anti Human IgG Conjugate 3. 1x 0.5 mL cANCA Positive 4. 1x 0.5 mL pANCA Positive 5. 1x 0.5mL IFA System Negative Control 6. 1x 25mL PBS II Concentrate (40x) 7. 1x 7mL Mounting Medium 8. 1x 10 Coverslips FDA UDI

Identifiers

Primary DI / UDI-DI
08426951026548 EUDAMED
08426950594055 EUDAMEDFDA UDI
08426950545798 EUDAMEDFDA UDI
Basic UDI-DI
B-08426951026548 EUDAMED
B-08426950594055 EUDAMED
B-08426950545798 EUDAMED
510(k) Number
K955431 FDA UDI
K961340 FDA UDI
FDA Product Code
DBL FDA UDI
MOB FDA UDI
EMDN Code
W0102100699 CELIAC DISEASE - OTHER EUDAMED
W0102100401 ANCA SCREENING EUDAMED
W0102100101,W0102109099 EUDAMED
GMDN Term
Intrinsic factor/parietal cell antibody IVD, kit, fluorescent immunoassay FDA UDI
Multiple anti-neutrophil cytoplasmic antibody (ANCA) IVD, kit, fluorescent immunoassay FDA UDI

Classification

Device Class
Class IVD General EUDAMED
Class II FDA UDI
Regulation Number
866.5660 FDA UDI
Market of Registration
Italy EUDAMED
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

EUDAMEDFDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Human Tissues

Yes

EUDAMED

Animal Tissues

Yes

EUDAMED

Microbial Substances

No

EUDAMED

Reagent

Yes

EUDAMED

Self Testing

No

EUDAMED

Near-Patient Testing

No

EUDAMED

Professional Testing

Yes

EUDAMED

Companion Diagnostics

No

EUDAMED

Surgical Instrument

No

EUDAMED

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

NOVA Lite by Inova Diagnostics, Inc. — Class IVD General — IVDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

CE/IVDD

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Inova Diagnostics. Inc.
EUDAMED SRN
US-MF-000017851
Authorised Representative
Medical Technology Promedt Consulting GmbH DE-AR-000000085

Sources (5)

  • EUDAMED b119d9ae-d58f-42c4-bce3-088b1e7ece9a 61 fields · synced Jul 22, 2026
  • EUDAMED b459203c-2052-4575-b3dc-c74809ceaad1 61 fields · synced May 18, 2026
  • FDA UDI 263573c3-aff0-4a69-854e-45e88ecea5e7 36 fields · synced May 22, 2026
  • FDA UDI 3e8ea978-272c-4cb2-a2cc-de7e1c45ea67 36 fields · synced May 30, 2026
  • EUDAMED a5245fda-7fd4-48ba-90ff-8588094ef65b 61 fields · synced Jul 22, 2026