Identity
- Trade Name
- AIMSTRIP URINE ANALYZER FDA UDI
- Generic Name
- Urine analyser IVD, point-of-care FDA UDI
- Device Name
- The AimStrip® Urine Analyzer / CT-120 Analyzer is intended for use in conjunction with the AimStrip® Urine Reagent Strips. FDA UDI
- Model / Reference
- 51120 FDA UDI
- Description
- The AimStrip® Urine Analyzer / CT-120 Analyzer is intended for use in conjunction with the AimStrip® Urine Reagent Strips. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00695684511203 FDA UDI
- FDA Product Code
- KQO FDA UDI
- GMDN Term
- Urine analyser IVD, point-of-care FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.2900 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Urine analyser IVD, point-of-care
Aimstrip Urine Analyzer by Germaine Laboratories, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Urine analyser IVD, point-of-care.
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- Mission U120 Urine Analyzer — ACON Laboratories, Inc. · Class I
- Rapid Response — BTNX Inc · Class I
- Mission U120 Urine Analyzer — ACON Laboratories, Inc. · Class I
- My Yodoc — S-CONNECT CO., LTD · Class I
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Germaine Laboratories, Inc.
Sources (1)
- FDA UDI a93946c0-439b-4f09-ab2f-ad7fc9f8c6ff 33 fields · synced Jun 1, 2026