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ANA Test Kit 15-113

by Antibodies Incorporated

ANA Test Kit 15-113 is a Class II device made by Antibodies Incorporated, listed in FDA GUDID since 20 Dec 2016 (UDI-DI 10862534000317), registry data as of 23 Oct 2026.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None

No authorization documents

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number10862534000317 UDI-DI Date20 Dec 2016ListedStatusListed GUDID: in commercial distribution

Official records

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade name
ANA Test Kit
Generic name
Multiple antinuclear antibody (ANA) IVD, kit, fluorescent immunoassay
Model / Ref / Catalog
15-113
Primary DI / UDI-DI
10862534000317
FDA product code
DHN
GMDN term
Multiple antinuclear antibody (ANA) IVD, kit, fluorescent immunoassay
Device class
Class II
Regulation number
866.5100
GUDID distribution status
In Commercial Distribution

Related devices

Category: Multiple antinuclear antibody (ANA) screening IVD, kit, fluorescent immunoassay

Similar devices in this category

Other devices filed under Multiple antinuclear antibody (ANA) screening IVD, kit, fluorescent immunoassay.

Other devices from Antibodies Incorporated

Properties

  • Single use
  • Convenience kit
  • Premarket exempt
  • Lot / batch number
  • Expiration date
Other properties (10, all answered No)