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NOVA Lite® HEp-2 External EB Kits

FDA UDI

Class II (US FDA UDI)

by Inova Diagnostics, Inc.

Identity

Trade Name
NOVA Lite® HEp-2 External EB Kits FDA UDI
Generic Name
Multiple antinuclear antibody (ANA) screening IVD, kit, fluorescent immunoassay FDA UDI
Device Name
1. 10x 6-well HEp 2 ANA Substrate Slides 2. 1x 1mL Homo. Ptn. (use w/Conj. 504070 or 504088) 3. 1x mL Centromere Positive Control 4. 1x 1mL IFA System Negative Control 5. 1x 7mL FITC IgG (H&L) HEp Conjugate 6. 1x 3mL PVA Mounting Medium 7. 2x 25mL PBS II Concentrate (40x) 8. 1x 3mL 1% Evans Blue 9. 1x 10 Coverslips FDA UDI
Model / Reference
704230 FDA UDI
Description
1. 10x 6-well HEp 2 ANA Substrate Slides 2. 1x 1mL Homo. Ptn. (use w/Conj. 504070 or 504088) 3. 1x mL Centromere Positive Control 4. 1x 1mL IFA System Negative Control 5. 1x 7mL FITC IgG (H&L) HEp Conjugate 6. 1x 3mL PVA Mounting Medium 7. 2x 25mL PBS II Concentrate (40x) 8. 1x 3mL 1% Evans Blue 9. 1x 10 Coverslips FDA UDI

Identifiers

Primary DI / UDI-DI
08426950595267 FDA UDI
FDA Product Code
DHN FDA UDI
GMDN Term
Multiple antinuclear antibody (ANA) screening 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

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

NOVA Lite® HEp-2 External EB Kits by Inova Diagnostics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Inova Diagnostics, Inc.

Sources (1)

  • FDA UDI 96c87589-891f-45d1-b211-02d337ada70c 36 fields · synced Jun 6, 2026