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ISE Internal Standard Gen.2 conc. 09137742190

by Roche Diagnostics Corp.

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 Number07613336222331 UDI-DI Date20 Mar 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  • Withdrawn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
ISE Internal Standard Gen.2 conc.
Generic Name
Multiple-type clinical chemistry analyte profile IVD, calibrator
Model / Ref / Catalog
09137742190
Primary DI / UDI-DI
07613336222331
FDA Product Code
JIT
GMDN Term
Multiple-type clinical chemistry analyte profile IVD, calibrator
Device Class
Class II
Regulation Number
862.1150
GUDID distribution status
In Commercial Distribution

Other devices from Roche Diagnostics Corp.

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Properties

  • Prescription Use
  • Premarket Exempt
  • Lot / Batch Number
  • Expiration Date

Other properties (10)

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