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IFA ASMA Test System

FDA UDI

by Zeus Scientific, Inc.

Identity

Trade Name
IFA ASMA Test System FDA UDI
Generic Name
Smooth muscle antibody IVD, kit, fluorescent immunoassay FDA UDI
Device Name
The ZEUS IFA Anti-Smooth Muscle Antibody (ASMA) Test System is designed for the qualitative and semi-quantitative detection of Smooth Muscle Antibodies (SMA) by the indirect fluorescent antibody (IFA) technique, and is for In Vitro diagnostic use. FDA UDI
Model / Reference
FA4001 FDA UDI
Description
The ZEUS IFA Anti-Smooth Muscle Antibody (ASMA) Test System is designed for the qualitative and semi-quantitative detection of Smooth Muscle Antibodies (SMA) by the indirect fluorescent antibody (IFA) technique, and is for In Vitro diagnostic use. FDA UDI

Identifiers

Catalog Number
FA4001 FDA UDI
Primary DI / UDI-DI
00845533001458 FDA UDI
GMDN Term
Smooth muscle antibody IVD, kit, fluorescent immunoassay FDA UDI

Classification

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

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

Category: Smooth muscle antibody IVD, kit, fluorescent immunoassay

IFA ASMA Test System by Zeus Scientific, Inc. — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Smooth muscle antibody IVD, kit, fluorescent immunoassay.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Zeus Scientific, Inc.

Sources (1)

  • FDA UDI 7a1a8963-2acb-455f-8801-2cd32b481759 35 fields · synced Jun 8, 2026