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JAS Diagnostics TPT2-1L

by Drew Scientific, Ltd.

JAS Diagnostics TPT2-1L is a Class II device made by Drew Scientific, Ltd., listed in FDA GUDID since 4 Apr 2017 (UDI-DI 00817274022474), 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 Number00817274022474 UDI-DI Date4 Apr 2017ListedStatusListed 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  • Withdrawn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
JAS Diagnostics
Generic name
Total protein IVD, reagent
Model / Ref / Catalog
TPT2-1L
Primary DI / UDI-DI
00817274022474
FDA product code
CEK
GMDN term
Total protein IVD, reagent
Device class
Class II
Regulation number
862.1635
GUDID distribution status
In Commercial Distribution

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Properties

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