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Aimstrip Us-9 59100

by Germaine Laboratories, Inc.

Aimstrip Us-9 59100 is a Class I device made by Germaine Laboratories, Inc., listed in FDA GUDID since 27 Apr 2016 (UDI-DI 00695684591007), 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 Number00695684591007 UDI-DI Date27 Apr 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  • Withdrawn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
Aimstrip Us-9
Generic name
Multiple urine analyte IVD, kit, rapid colorimetric, clinical
Model / reference
59100
Primary DI / UDI-DI
00695684591007
FDA product code
KQO, JRE, JMT, JJB, JIR, JIO, JIN, JIL, CEN, CDM
GMDN term
Multiple urine analyte IVD, kit, rapid colorimetric, clinical
Device class
Class I
Regulation number
862.2900, 862.2800, 862.1510, 862.1115, 862.1645, 864.6550, 862.1435, 862.1340, 862.1550, 862.1785
GUDID distribution status
In Commercial Distribution

Related devices

Category: Multiple urine analyte IVD, kit, rapid colorimetric, clinicalUrine glucose IVD, kit, rapid colorimetric, clinicalUrine ketone IVD, kit, rapid colorimetric, clinicalUrine protein IVD, kit, rapid colorimetric, clinical

Similar devices

Other devices filed under FDA product code KQO (Automated Urinalysis System).

Other devices from Germaine Laboratories, Inc.

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Properties

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