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Filaria Antibody 96 Tests

FDA UDI

Class I (US FDA UDI)

by Scimedx Corp.

Identity

Trade Name
Filaria Antibody 96 Tests FDA UDI
Generic Name
Wuchereria bancrofti/Brugia malayi immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA) FDA UDI
Model / Reference
FI-96 FDA UDI

Identifiers

Catalog Number
FI-96 FDA UDI
Primary DI / UDI-DI
00813545025427 FDA UDI
FDA Product Code
LIB FDA UDI
GMDN Term
Wuchereria bancrofti/Brugia malayi immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA) FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
866.2660 FDA UDI
Commercial Distribution
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

No

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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Wuchereria bancrofti/Brugia malayi immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

Filaria Antibody 96 Tests by Scimedx Corp. — Class I — 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
Scimedx Corp.

Sources (1)

  • FDA UDI d8e98c0d-8164-4778-bafd-f23ceff62175 34 fields · synced Jun 8, 2026