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LaCAR 0974

by Lacar MDX Technologies Belgium GUDID

Product code JJY

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number05430003908518 UDI-DIDate15 Jan 2026ListedStatusIn distribution

Coverage

1 jurisdiction

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  • Listed
  • Not covered

United States — GUDID listing Listed

Recalls: none on record (FDA, checked 23 Oct 2026)

Specification

GUDID · synced 23 Oct 2026

Trade Name
LaCAR
Generic Name
Newborn metabolic screen/congenital disorder IVD, control
Model / Ref / Catalog
0974
Primary DI / UDI-DI
05430003908518
FDA Product Code
JJY
GMDN Term
Newborn metabolic screen/congenital disorder IVD, control
Device Class
Class I
Regulation Number
862.1660
Commercial Distribution
In Commercial Distribution

Other devices from Lacar MDX Technologies

See all devices from Lacar MDX Technologies →

Properties & raw data

Show properties, registry sources and raw records
  • Premarket Exempt
  • Lot / Batch Number
  • Expiration Date
  • 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
  • Serial Number: No

Sources (1)

  • FDA UDI b4b4904d-48e3-4954-94af-550f31e868c3 36 fields · synced 23 Oct 2026