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Leptospira IgG Antibody 96 Test

FDA UDI

Class II (US FDA UDI)

by Scimedx Corp.

Identity

Trade Name
Leptospira IgG Antibody 96 Test FDA UDI
Generic Name
Multiple Leptospira species immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA) FDA UDI
Model / Reference
LEPTO-G FDA UDI

Identifiers

Catalog Number
LEPTO-G FDA UDI
Primary DI / UDI-DI
00813545026318 FDA UDI
FDA Product Code
GRY FDA UDI
GMDN Term
Multiple Leptospira species immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA) FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
866.3350 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: Multiple Leptospira species immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

Leptospira IgG Antibody 96 Test by Scimedx Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Multiple Leptospira species immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA).

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Scimedx Corp.

Sources (1)

  • FDA UDI 92a8de12-ee39-4711-8d2d-4ac5ca87696e 34 fields · synced May 30, 2026