FDA.reportPublic FDA data

Rapid Response

Primary DI
00722066005255
Brand
Rapid Response
Company
BTNX Inc
Model
U11.1-1S100
Device description
Rapid Response 11 Parameter Urinalysis Reagent Strips (ASC/GLU/BLD/LEU/PRO/NIT/KET/PH/BIL/URO/SG) - 100 tests/ kit are for qualitative or semi-quantitative determination of Ascorbic Acid, Glucose, Blood, Leukocyte, Protein, Nitrite, Ketone, pH, Bilirubin, Urobilinogen, Specific Gravity in urine.
Published
2020-12-14
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
CENDye-Indicator, Ph (Urinary, Non-Quantitative)
JILMethod, Enzymatic, Glucose (Urinary, Non-Quantitative)
JINNitroprusside, Ketones (Urinary, Non-Quant.)
JIOBlood, Occult, Colorimetric, In Urine
JIRIndicator Method, Protein Or Albumin (Urinary, Non-Quant.)
JJBAzo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.)
JMAAcid, Ascorbic, 2,4-Dinitrophenylhydrazine (Spectrophotometric)
JMTDiazo (Colorimetric), Nitrite (Urinary, Non-Quant)
JRERefractometer For Clinical Use
LJXTest, Urine Leukocyte

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CENDye-Indicator, Ph (Urinary, Non-Quantitative)Clinical Chemistry1
JILMethod, Enzymatic, Glucose (Urinary, Non-Quantitative)Clinical Chemistry2
JINNitroprusside, Ketones (Urinary, Non-Quant.)Clinical Chemistry1
JIOBlood, Occult, Colorimetric, In UrineHematology2
JIRIndicator Method, Protein Or Albumin (Urinary, Non-Quant.)Clinical Chemistry1
JJBAzo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.)Clinical Chemistry1
JMAAcid, Ascorbic, 2,4-Dinitrophenylhydrazine (Spectrophotometric)Clinical Chemistry1
JMTDiazo (Colorimetric), Nitrite (Urinary, Non-Quant)Clinical Chemistry1
JRERefractometer For Clinical UseClinical Chemistry1
LJXTest, Urine LeukocyteHematology1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K061559000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K061559000ACON URINALYSIS REAGENT STRIPSAcon Laboratories Co.2006-08-11CDM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00722066005255PrimaryGS10
00722066005262Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00722066005255007220660052557220660052550722066005255
00722066005262007220660052627220660052620722066005262

GMDN Terms#

Term, Definition table
TermDefinition
Urine specific gravity IVD, kit, colorimetric dipstick, rapidA collection of reagents and other associated materials intended to be used for the qualitative and/or semi-quantitative screening of urine to determine specific gravity within a short period relative to standard laboratory testing procedures, using a colorimetric dipstick method. This test is commonly used in the laboratory or in point-of-care analyses.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
251005005
Device count
100
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10722066015053Rapid ResponseD12.49-1VAF2026-05-15
10722066015084Rapid ResponseD13.5-1VF2026-05-15
10722066011260Rapid ResponseD13.5-1VF2026-01-19
10722066011277Rapid ResponseD12.49-1VAF2026-01-19
20722066011267Rapid ResponseD13.5-1VF2026-01-19
20722066011274Rapid ResponseD12.49-1VAF2026-01-19
10722066011338Rapid ResponseFOB-9C36FOB-9C362026-01-02
20722066011335Rapid ResponseFOB-9C36FOB-9C362026-01-02
00722066000205Rapid ResponseHCG-3C50HCG-3C502016-10-25
00722066000267Rapid ResponseHCG-3C25HCG-3C252016-10-25
00722066004548Rapid ResponseD12.5-1V2019-01-21
10722066009083Rapid ResponseD12.49-1VA2025-10-03
10722066010973Rapid ResponseD13.5-1V2025-07-08
00722066010976Rapid ResponseD13.5-1V2025-07-08
10722066009601Rapid ResponseCOF-19CGHU22025-05-29
10722066009618Rapid ResponseCOF-19CGHU42025-05-29
10722066010751Rapid ResponseSTR-15SGPU-252025-05-29
10722066009595Rapid ResponseCOF-19CGHU12025-05-29
00722066009604Rapid ResponseCOF-19CGHU22025-05-29
00722066009611Rapid ResponseCOF-19CGHU42025-05-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10612479279886MckessonMCKESSON MEDICAL-SURGICAL INC.JIO2025-09-18
10612479279886MckessonMCKESSON MEDICAL-SURGICAL INC.JMA2025-09-18
10612479279886MckessonMCKESSON MEDICAL-SURGICAL INC.JJB2025-09-18
10612479279886MckessonMCKESSON MEDICAL-SURGICAL INC.CEN2025-09-18
10612479279886MckessonMCKESSON MEDICAL-SURGICAL INC.LJX2025-09-18
10612479279886MckessonMCKESSON MEDICAL-SURGICAL INC.JIR2025-09-18
10612479279886MckessonMCKESSON MEDICAL-SURGICAL INC.JIN2025-09-18
10612479279886MckessonMCKESSON MEDICAL-SURGICAL INC.JMT2025-09-18
10612479279886MckessonMCKESSON MEDICAL-SURGICAL INC.JRE2025-09-18
08806141303497One+Step 10ADFI CO.,LTDJRE2023-10-16
08806141303497One+Step 10ADFI CO.,LTDCEN2023-10-16
08806141303497One+Step 10ADFI CO.,LTDJIN2023-10-16
08806141303497One+Step 10ADFI CO.,LTDJMT2023-10-16
08806141303497One+Step 10ADFI CO.,LTDJMA2023-10-16
08806141303497One+Step 10ADFI CO.,LTDJIR2023-10-16
08806141303497One+Step 10ADFI CO.,LTDJJB2023-10-16
08806141303480One+Step UTIDFI CO.,LTDJMT2023-10-14
08806141303480One+Step UTIDFI CO.,LTDCEN2023-10-14
00860010249000Starling Medical, IncStarling Medical, Inc.JMT2023-05-22
00860010249017Starling Medical, IncStarling Medical, Inc.JMT2023-05-22
00860010249024Starling Medical, IncStarling Medical, Inc.JMT2023-05-22
08806141302209Just Fitter 10 Parameter Test Strips DFI CO.,LTDJIL2020-09-22
08806141302209Just Fitter 10 Parameter Test Strips DFI CO.,LTDJIR2020-09-22
08806141302209Just Fitter 10 Parameter Test Strips DFI CO.,LTDJIO2020-09-22
08806141302209Just Fitter 10 Parameter Test Strips DFI CO.,LTDCEN2020-09-22
08806141302209Just Fitter 10 Parameter Test Strips DFI CO.,LTDJIN2020-09-22
08806141302209Just Fitter 10 Parameter Test Strips DFI CO.,LTDJJB2020-09-22
08806141302209Just Fitter 10 Parameter Test Strips DFI CO.,LTDLJX2020-09-22
08806141302209Just Fitter 10 Parameter Test Strips DFI CO.,LTDJRE2020-09-22
08806141302209Just Fitter 10 Parameter Test Strips DFI CO.,LTDJMT2020-09-22