Skip to content

Lipoprint System (Domestic) 48-9150

by Quantimetrix Corp.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00896863002448 UDI-DI Date14 Sep 2026ListedStatusListed GUDID: in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Lipoprint System (Domestic)
Generic Name
Total lipoprotein IVD, control
Model / Ref / Catalog
48-9150
Primary DI / UDI-DI
00896863002448
510(k) Number
FDA Product Code
JJY, JHO
GMDN Term
Total lipoprotein IVD, control
Device Class
Class I
Regulation Number
862.1660, 862.1475
GUDID distribution status
In Commercial Distribution

Related devices

Cleared under the same submission (K010337)

Cleared under the same submission (K013662)

Other devices from Quantimetrix Corp.

See all devices from Quantimetrix Corp. →

Properties

  • Convenience Kit

Other properties (13)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Prescription Use: No
  • Over-the-Counter: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Lot / Batch Number: No
  • Serial Number: No
  • Expiration Date: No
  • Manufacturing Date: No