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EL-ANA Profiles: anti-ssDNA

FDA UDI

by Theratest Laboratories, Inc.

Identity

Trade Name
EL-ANA Profiles: anti-ssDNA FDA UDI
Generic Name
Single stranded DNA antibody (anti-ssDNA) IVD, kit, enzyme immunoassay (EIA) FDA UDI
Device Name
ANTI-SINGLE STRANDED DNA ANTIBODY ELISA TEST KIT, 96 TESTS FDA UDI
Model / Reference
104-101 FDA UDI
Description
ANTI-SINGLE STRANDED DNA ANTIBODY ELISA TEST KIT, 96 TESTS FDA UDI

Identifiers

Catalog Number
104-101 FDA UDI
Primary DI / UDI-DI
00854473003095 FDA UDI
510(k) Number
K051066 FDA UDI
GMDN Term
Single stranded DNA antibody (anti-ssDNA) 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: Single stranded DNA antibody (anti-ssDNA) IVD, kit, enzyme immunoassay (EIA)

EL-ANA Profiles: anti-ssDNA 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

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Manufacturer

Manufacturer
Theratest Laboratories, Inc.

Sources (1)

  • FDA UDI bf6d6aec-af05-4b37-9491-13b0abbc6761 36 fields · synced May 30, 2026