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Costcare B120i-W

by Fujian Pacific Medical Manufacturing Co., Ltd

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

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number06979878770329 UDI-DI Date21 Aug 2026ListedStatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Costcare
Generic Name
Rickettsia prowazekii immunoglobulin A (IgA)/IgG/IgM antibody IVD, control
Model / Reference
B120i-W
Primary DI / UDI-DI
06979878770329
FDA Product Code
FNL
GMDN Term
Rickettsia prowazekii immunoglobulin A (IgA)/IgG/IgM antibody IVD, control
Device Class
Class II
Regulation Number
880.5100
GUDID distribution status
In Commercial Distribution

Other devices from Fujian Pacific Medical Manufacturing Co., Ltd

See all devices from Fujian Pacific Medical Manufacturing Co., Ltd →

Properties

  • Premarket Exempt
  • Lot / Batch Number
  • Serial Number
  • Manufacturing Date

Other properties (10)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Expiration Date: No