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Enzymatic Cholesterol 2145-0

by Sterling Diagnostics Inc

Enzymatic Cholesterol 2145-0 is a device made by Sterling Diagnostics Inc, listed in FDA GUDID since 14 Sep 2016 (UDI-DI 00852223007010), registry data as of 22 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 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00852223007010 UDI-DI Date14 Sep 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  • Withdrawn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
Enzymatic Cholesterol
Generic name
Total cholesterol lipid IVD, reagent
Model / Ref / Catalog
2145-0
Primary DI / UDI-DI
00852223007010
GMDN term
Total cholesterol lipid IVD, reagent
GUDID distribution status
In Commercial Distribution

Related devices

Category: Total cholesterol lipid IVD, reagent

Similar devices in this category

Other devices filed under Total cholesterol lipid IVD, reagent.

Other devices from Sterling Diagnostics Inc

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Properties

  • Convenience kit
  • Premarket exempt
  • Lot / batch number
  • Expiration date
Other properties (11, all answered No)