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Detector Lex SLE

FDA UDI

Class II (US FDA UDI)

by Immunostics, Inc.

Identity

Trade Name
Detector Lex SLE FDA UDI
Generic Name
Multiple systemic lupus erythematosus (SLE)-associated antibody IVD, reagent FDA UDI
Device Name
A rapid undiluted latex agglutination slide test for the detection of anti-nucleoprotein serum factors associated with systemic lupus erythematosus (sLE) FDA UDI
Model / Reference
SLE-100 FDA UDI
Description
A rapid undiluted latex agglutination slide test for the detection of anti-nucleoprotein serum factors associated with systemic lupus erythematosus (sLE) FDA UDI

Identifiers

Primary DI / UDI-DI
10722355001729 FDA UDI
FDA Product Code
DHC FDA UDI
GMDN Term
Multiple systemic lupus erythematosus (SLE)-associated antibody IVD, reagent FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
866.5820 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

Yes

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

Yes

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: Multiple systemic lupus erythematosus (SLE)-associated antibody IVD, reagent

Detector Lex SLE by Immunostics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Multiple systemic lupus erythematosus (SLE)-associated antibody IVD, reagent.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Immunostics, Inc.

Sources (1)

  • FDA UDI bcf82f72-ed6b-43b9-ab97-d7e2261b23ab 35 fields · synced Jun 8, 2026