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El-Ana Profiles: Ana/9

FDA UDI

by Theratest Laboratories, Inc.

Identity

Trade Name
EL-ANA PROFILES: ANA/9 FDA UDI
Generic Name
Centromere protein antibody (anti-CENP) IVD, kit, enzyme immunoassay (EIA) FDA UDI
Device Name
ANTI-NUCLEAR ANTIBODY ELISA TEST KIT, 40 TESTS OF 9 INDIVIDUAL ANTIGENS FDA UDI
Model / Reference
104-005 FDA UDI
Description
ANTI-NUCLEAR ANTIBODY ELISA TEST KIT, 40 TESTS OF 9 INDIVIDUAL ANTIGENS FDA UDI

Identifiers

Catalog Number
104-005 FDA UDI
Primary DI / UDI-DI
00854473003071 FDA UDI
510(k) Number
K051066 FDA UDI
GMDN Term
Centromere protein antibody (anti-CENP) 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)Scleroderma-70 antibody (anti-Scl-70) IVD, kit, enzyme immunoassay (EIA)Sm/RNP antibody IVD, kit, enzyme immunoassay (EIA)SSB/La antibody (Sjogren's antibody) IVD, kit, enzyme immunoassay (EIA)

El-Ana Profiles: Ana/9 by Theratest Laboratories, Inc. — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Centromere protein antibody (anti-CENP) 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

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Manufacturer

Manufacturer
Theratest Laboratories, Inc.

Sources (1)

  • FDA UDI 7a4619f7-d0a1-4b46-b2f4-203894f9fa5b 36 fields · synced May 30, 2026