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InflammaDry RPS-ID-20

by Quidel Corp.

Ref RPS-ID-20Model InflammaDry - 20 Test

InflammaDry RPS-ID-20 is a device classified as IVD General (EU), Class I (US) made by Quidel Corp., registered in EUDAMED on 4 Nov 2026 (Basic UDI-DI B-30014613336747), cleared under FDA 510(k) K132066 on 21 Nov 2013 and listed in FDA GUDID since 2 Aug 2019 (UDI-DI 30014613336747), active as of 7 Nov 2026. 3 FDA recalls are linked to it.

Active European Union and United States. Also listed in GUDID (US).

CE IVDD 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

2 ongoing

This device is named in the recall

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K132066

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD EUDAMED NumberB-30014613336747 Basic UDI-DI 30014613336747UDI-DIDate4 Nov 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number30014613336747 UDI-DI Date2 Aug 2019ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK132066 Date21 Nov 2013DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-30014613336747 registered 4 Nov 2026 Active
  • FDA 510(k) K132066 decided 21 Nov 2013 Active
  • FDA GUDID UDI-DI 30014613336747 listed 2 Aug 2019 Listed

Recalls

3 recalls · 2 ongoing · FDA

  • 2 recalls, same reason

    • Ongoing Z-1636-2024 FDA Class II initiated 5 Mar 2024
    • Ongoing Z-1637-2024 FDA Class II initiated 5 Mar 2024

    There are two windows on the test device, the control line window and the test results window. The line for the test results window were misaligned. In instances of positive test results, the positivite test line may not be visible/ hidden under the cassette of the test device thus potentially leading to a false negative result.

    • Terminated Z-2803-2017 FDA Class II initiated 22 Jun 2017

    In-house testing revealed the presence of plastic spurs at the tips of some Sample Collectors.

Timeline

6 dated events

  1. Cleared FDA 510(k) K132066
  2. Recall initiated FDA recalls Z-2803-2017
  3. Listed FDA GUDID 30014613336747
  4. Recall initiated FDA recalls Z-1636-2024
  5. Recall initiated FDA recalls Z-1637-2024
  6. Registered EUDAMED B-30014613336747

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/IVDD Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
InflammaDry - 20 Test EUDAMED
InflammaDry GUDID
Generic name
Matrix metalloproteinase-9 (MMP-9) IVD, kit, rapid ICT, clinical
Model / Ref / Catalog
RPS-ID-20, InflammaDry - 20 Test
Primary DI / UDI-DI
30014613336747
Basic UDI-DI
B-30014613336747
510(k) Number
FDA product code
PFQ, JJX
EMDN code
W01010199 Enzymes - other
GMDN term
Matrix metalloproteinase-9 (MMP-9) IVD, kit, rapid ICT, clinical
Device class
Class IVD General EUDAMED
Class I GUDID
Regulation number
862.1540, 862.1660
EU registration type
Legacy device (under a directive)
EU market of registration
Austria
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Device classEUDAMED
Class IVD General
GUDID
Class I
Supplied sterileEUDAMED
Yes
GUDID
No

Registry differences

EUDAMED and FDA GUDID describe the same product (same UDI-DI) and state different values:

  • Supplied sterile UDI-DI 30014613336747: EUDAMED states Yes, FDA GUDID states No.

Device class is stated on each registry's own scale: Class IVD General in the EU (EUDAMED), Class I in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Matrix metalloproteinase-9 (MMP-9) IVD, kit, rapid ICT, clinical

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Other devices filed under ENZYMES - OTHER.

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Properties

  • Supplied sterile YesEUDAMEDNoGUDID
  • Single use
  • IVD kit
  • Near-patient testing
  • Professional testing
  • Prescription use
  • Convenience kit
  • Lot / batch number
  • Expiration date
Other properties (17, all answered No)