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Rapid Response

FDA UDI

Class I (US FDA UDI)

by BTNX Inc

Identity

Trade Name
Rapid Response FDA UDI
Generic Name
Urine protein IVD, kit, rapid colorimetric, clinical FDA UDI
Device Name
Rapid Response 10 Parameter Urinalysis Reagent Strips (GLU/BIL/KET/SG/BLO/PH/PRO/URO/NIT/LEU) - 25 tests/ kit are for qualitative or semi-quantitative detection of Glucose, Bilirubin, Ketone, Specific Gravity, Blood, pH, Protein, Urobilinogen, Nitrite, Leukocytes in urine. FDA UDI
Model / Reference
U10.1-1S25 FDA UDI
Description
Rapid Response 10 Parameter Urinalysis Reagent Strips (GLU/BIL/KET/SG/BLO/PH/PRO/URO/NIT/LEU) - 25 tests/ kit are for qualitative or semi-quantitative detection of Glucose, Bilirubin, Ketone, Specific Gravity, Blood, pH, Protein, Urobilinogen, Nitrite, Leukocytes in urine. FDA UDI

Identifiers

Catalog Number
U10.1-1S25 FDA UDI
Primary DI / UDI-DI
00722066003022 FDA UDI
510(k) Number
K061559 FDA UDI
FDA Product Code
JJB FDA UDI
CDM FDA UDI
JIN FDA UDI
JIR FDA UDI
JMT FDA UDI
CEN FDA UDI
LJX FDA UDI
JIO FDA UDI
JIL FDA UDI
GMDN Term
Urine protein IVD, kit, rapid colorimetric, clinical FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
862.1115 FDA UDI
862.1785 FDA UDI
862.1435 FDA UDI
862.1645 FDA UDI
862.1510 FDA UDI
862.1550 FDA UDI
864.7675 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

Yes

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 glucose IVD, kit, rapid colorimetric, clinicalUrine ketone IVD, kit, rapid colorimetric, clinicalUrine protein IVD, kit, rapid colorimetric, clinicalUrine blood IVD, kit, rapid colorimetric, clinical

Rapid Response by BTNX 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.

Cleared under the same submission

K061559 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
BTNX Inc

Sources (1)

  • FDA UDI f7e73670-fb3d-463f-88a7-9e20e0378c00 35 fields · synced May 30, 2026