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NOVA Gel® Scl-70 “T” Extractable Nuclear Autoantibody Reagents

FDA UDI

Class II (US FDA UDI)

by Inova Diagnostics, Inc.

Identity

Trade Name
NOVA Gel® Scl-70 “T” Extractable Nuclear Autoantibody Reagents FDA UDI
Generic Name
Multiple extractable nuclear antigen antibody (anti-ENA) screening IVD, kit, precipitation/immunodiffusion FDA UDI
Device Name
1. 8 Prepunched NOVA Gel titering “T” plates 2. 2 0.4mL Scl-70 antigen, lyophilized 3. 1 1.4mL Scl-70 Control FDA UDI
Model / Reference
708475 FDA UDI
Description
1. 8 Prepunched NOVA Gel titering “T” plates 2. 2 0.4mL Scl-70 antigen, lyophilized 3. 1 1.4mL Scl-70 Control FDA UDI

Identifiers

Primary DI / UDI-DI
08426950595311 FDA UDI
FDA Product Code
LLL FDA UDI
GMDN Term
Multiple extractable nuclear antigen antibody (anti-ENA) screening IVD, kit, precipitation/immunodiffusion 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 Gel® Scl-70 “T” Extractable Nuclear Autoantibody Reagents by Inova Diagnostics, Inc. — Class II — FDA UDI — listed in FDA GUDID

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 d148d1d5-8a4d-48ed-911b-38266666ca6f 36 fields · synced May 31, 2026