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Aimstrip Us-5b

FDA UDI

Class I (US FDA UDI)

by Germaine Laboratories, Inc.

Identity

Trade Name
AIMSTRIP US-5B FDA UDI
Generic Name
Multiple urine analyte IVD, kit, rapid colorimetric, clinical FDA UDI
Device Name
Dipstick reagent strips for the qualitative detection of the following : Blood, Glucose, Protein, Nitrite and Leukocytes in Urine. FDA UDI
Model / Reference
55200 FDA UDI
Description
Dipstick reagent strips for the qualitative detection of the following : Blood, Glucose, Protein, Nitrite and Leukocytes in Urine. FDA UDI

Identifiers

Primary DI / UDI-DI
00695684552008 FDA UDI
FDA Product Code
LJX FDA UDI
KQO FDA UDI
JRE FDA UDI
JMT FDA UDI
JIR FDA UDI
JIO FDA UDI
JIL FDA UDI
GMDN Term
Multiple urine analyte IVD, kit, rapid colorimetric, clinical FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
864.7675 FDA UDI
862.2900 FDA UDI
862.2800 FDA UDI
862.1510 FDA UDI
862.1645 FDA UDI
864.6550 FDA UDI
862.1340 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 protein IVD, kit, rapid colorimetric, clinicalUrine blood IVD, kit, rapid colorimetric, clinical

Aimstrip Us-5b by Germaine Laboratories, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Urine leukocyte IVD, kit, rapid colorimetric, clinical.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Germaine Laboratories, Inc.

Sources (1)

  • FDA UDI 791f16d7-d387-4b22-a0fc-e843372e808e 33 fields · synced Jun 6, 2026