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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. 20x 12-well HEp 2 ANA Substrate Slides 2. 1x 1mL Homo. Ptn. (use w/Conj. 504070 or 504088) 3. 1x 1 mL Centromere Positive Control 4. 1x 1mL IFA System Negative Control 5. 1x 15mL FITC IgG (H&L) HEp Conjugate 7. 1x 10mL PVA Mounting Medium 8. 2x 25mL PBS II Concentrate (40x) 9. 1x 3mL 1% Evans Blue 10.1x 20 Coverslips FDA UDI
Model / Reference
704235 FDA UDI
Description
1. 20x 12-well HEp 2 ANA Substrate Slides 2. 1x 1mL Homo. Ptn. (use w/Conj. 504070 or 504088) 3. 1x 1 mL Centromere Positive Control 4. 1x 1mL IFA System Negative Control 5. 1x 15mL FITC IgG (H&L) HEp Conjugate 7. 1x 10mL PVA Mounting Medium 8. 2x 25mL PBS II Concentrate (40x) 9. 1x 3mL 1% Evans Blue 10.1x 20 Coverslips FDA UDI

Identifiers

Primary DI / UDI-DI
08426950594208 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 2b2b77d1-0225-42f4-be8b-20b39ac5648f 36 fields · synced May 31, 2026