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EL-ANA PROFILES: EL-ANAscr

FDA UDI

by Theratest Laboratories, Inc.

Identity

Trade Name
EL-ANA PROFILES: EL-ANAscr FDA UDI
Generic Name
Multiple systemic lupus erythematosus (SLE)-associated antibody IVD, kit, enzyme immunoassay (EIA) FDA UDI
Device Name
ANTI-NUCLEAR ANTIBODY SCREEN ELISA TEST KIT, 192 TESTS FDA UDI
Model / Reference
100-004 FDA UDI
Description
ANTI-NUCLEAR ANTIBODY SCREEN ELISA TEST KIT, 192 TESTS FDA UDI

Identifiers

Catalog Number
100-004 FDA UDI
Primary DI / UDI-DI
00854473003057 FDA UDI
510(k) Number
K954106 FDA UDI
GMDN Term
Multiple systemic lupus erythematosus (SLE)-associated antibody IVD, kit, enzyme immunoassay (EIA) 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

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

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, kit, enzyme immunoassay (EIA)

EL-ANA PROFILES: EL-ANAscr by Theratest Laboratories, Inc. — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Multiple systemic lupus erythematosus (SLE)-associated antibody IVD, kit, enzyme immunoassay (EIA).

Cleared under the same submission

K954106 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Theratest Laboratories, Inc.

Sources (1)

  • FDA UDI 9480b4fe-1d6e-4de6-a74e-6b8ca28f242b 36 fields · synced May 29, 2026