← Back to catalogue

NOVA Lite

EUDAMEDFDA UDI

Class IVD General (EU MDR)

Ref 708390

by Inova Diagnostics. Inc.

Identity

Trade Name
NOVA Lite EUDAMED
NOVA Lite® ANA KSL Kit FDA UDI
Generic Name
Intrinsic factor/parietal cell antibody IVD, kit, fluorescent immunoassay FDA UDI
Device Name
NOVA Lite® ANA KSL Kit EUDAMED
1. 10x 4-well ANA KSL Substrate Slides 2. 1x 7mL FITC Anti Human IgG Conjugate 3. 1x 0.5 mL ANA Homogeneous Pattern 4. 1x 0.5mL IFA System Negative Control 5. 1x 25mL PBS Concentrate (40x) 6. 1x 7mL Mounting Medium 7. 1x 10 Coverslips FDA UDI
Model / Reference
708390 EUDAMEDFDA UDI
Description
1. 10x 4-well ANA KSL Substrate Slides 2. 1x 7mL FITC Anti Human IgG Conjugate 3. 1x 0.5 mL ANA Homogeneous Pattern 4. 1x 0.5mL IFA System Negative Control 5. 1x 25mL PBS Concentrate (40x) 6. 1x 7mL Mounting Medium 7. 1x 10 Coverslips FDA UDI

Identifiers

Primary DI / UDI-DI
08426950506324 EUDAMEDFDA UDI
Basic UDI-DI
B-08426950506324 EUDAMED
510(k) Number
K901596 FDA UDI
FDA Product Code
DHN FDA UDI
EMDN Code
W0102100101 ANA SCREENING EUDAMED
GMDN Term
Intrinsic factor/parietal cell antibody IVD, kit, fluorescent immunoassay FDA UDI

Classification

Device Class
Class IVD General EUDAMED
Class II FDA UDI
Regulation Number
866.5100 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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

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

Sources (2)

  • EUDAMED 4020c683-de1b-47bb-a263-e8a9f798e64e 61 fields · synced Jun 1, 2026
  • FDA UDI 87fb7354-e4c5-436a-b85c-b71ce3195e1b 36 fields · synced May 30, 2026