← Back to catalogue

El-Ana Profiles: Ana/4

FDA UDI

by Theratest Laboratories, Inc.

Identity

Trade Name
EL-ANA PROFILES: ANA/4 FDA UDI
Generic Name
Multiple systemic lupus erythematosus (SLE)-associated antibody IVD, kit, enzyme immunoassay (EIA) FDA UDI
Device Name
ANTI-NUCLEAR ANTIBODY ELISA TEST KIT, 24 TESTS OF 4 INDIVIDUAL ANTIGENS FDA UDI
Model / Reference
105-002 FDA UDI
Description
ANTI-NUCLEAR ANTIBODY ELISA TEST KIT, 24 TESTS OF 4 INDIVIDUAL ANTIGENS FDA UDI

Identifiers

Catalog Number
105-002 FDA UDI
Primary DI / UDI-DI
00854473003309 FDA UDI
510(k) Number
K051066 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

No

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: Double stranded DNA antibody (anti-dsDNA) IVD, kit, enzyme immunoassay (EIA)Sm/RNP antibody IVD, kit, enzyme immunoassay (EIA)Multiple systemic lupus erythematosus (SLE)-associated antibody IVD, kit, enzyme immunoassay (EIA)Single stranded DNA antibody (anti-ssDNA) IVD, kit, enzyme immunoassay (EIA)

El-Ana Profiles: Ana/4 by Theratest Laboratories, Inc. — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Single stranded DNA antibody (anti-ssDNA) IVD, kit, enzyme immunoassay (EIA).

Cleared under the same submission

K051066 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Theratest Laboratories, Inc.

Sources (1)

  • FDA UDI b6f11fff-7560-4912-badf-03184f473109 36 fields · synced Jun 8, 2026