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PlasmaRef ARN 33-201

by r2 Diagnostics Inc.

PlasmaRef ARN 33-201 is a Class II device made by r2 Diagnostics Inc., listed in FDA GUDID since 15 Nov 2016 (UDI-DI 10859394006177), registry data as of 23 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 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number10859394006177 UDI-DI Date15 Nov 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  • Withdrawn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
PlasmaRef ARN
Generic name
Plasma protein IVD, calibrator
Model / Ref / Catalog
33-201
Primary DI / UDI-DI
10859394006177
FDA product code
GGN
GMDN term
Plasma protein IVD, calibrator
Device class
Class II
Regulation number
864.5425
GUDID distribution status
In Commercial Distribution

Related devices

Category: Plasma protein IVD, calibrator

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Other devices from r2 Diagnostics Inc.

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Properties

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