Identity
- Trade Name
- AIMSTRIP 10-SG FDA UDI
- Generic Name
- Urine leukocyte IVD, kit, rapid colorimetric, clinical FDA UDI
- Device Name
- Dipstick reagent strips for the qualitative detection of the following : Glucose, Bilirubin, Ketone, Specific Gravity, Blood, pH, Protein, Urobilinogen, Nitrite and Leukocytes in Urine. FDA UDI
- Model / Reference
- 51100 FDA UDI
- Description
- Dipstick reagent strips for the qualitative detection of the following : Glucose, Bilirubin, Ketone, Specific Gravity, Blood, pH, Protein, Urobilinogen, Nitrite and Leukocytes in Urine. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00695684511005 FDA UDI
- FDA Product Code
- KQO FDA UDIJRE FDA UDICDM FDA UDIJIR FDA UDICEN FDA UDIJMT FDA UDIJIN FDA UDIJIL FDA UDIJJB FDA UDILJX FDA UDIJIO FDA UDI
- GMDN Term
- Urine leukocyte IVD, kit, rapid colorimetric, clinical FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.2900 FDA UDI862.2800 FDA UDI862.1785 FDA UDI862.1645 FDA UDI862.1550 FDA UDI862.1510 FDA UDI862.1435 FDA UDI862.1340 FDA UDI862.1115 FDA UDI864.7675 FDA UDI864.6550 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: 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
Aimstrip 10-Sg by Germaine Laboratories, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Urine urobilinogen IVD, kit, rapid colorimetric, clinical.
- Tanner Scientific® — MERCEDES MEDICAL LLC · Class I
- Rapid Response — BTNX Inc · Class I
- Rapid Response — BTNX Inc · Class I
- Rapid Response — BTNX Inc · Class I
- AIMSTRIP US-9 — GERMAINE LABORATORIES, INC. · Class I
- AIMSTRIP US-11 — GERMAINE LABORATORIES, INC. · 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Germaine Laboratories, Inc.
Sources (1)
- FDA UDI b24d186f-0c3b-4b51-9c08-1d7dfa11f75b 33 fields · synced Jun 1, 2026