FDA.reportPublic FDA data

Rapid Response

Primary DI
00722066003022
Brand
Rapid Response
Company
BTNX Inc
Model
U10.1-1S25
Catalog number
U10.1-1S25
Device 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.
Published
2016-10-17
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
CDMDiazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.)
CENDye-Indicator, Ph (Urinary, Non-Quant.)
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.)
JMTDiazo (Colorimetric), Nitrite (Urinary, Non-Quant)
LJXTest, Urine Leukocyte

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CDMDiazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.)Clinical Chemistry1
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
JMTDiazo (Colorimetric), Nitrite (Urinary, Non-Quant)Clinical 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
00722066003022PrimaryGS10
00722066003794Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00722066003022007220660030227220660030220722066003022
00722066003794007220660037947220660037940722066003794

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
251005005
Device count
25
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10722066005511Rapid ResponseD6.6.3-1V2026-10-09
10722066018979Rapid ResponseD10.3-1VF2026-10-08
10722066019013Rapid ResponseD10.32-1VF2026-10-08
10722066019020Rapid ResponseD5.75-1VF2026-10-08
10722066019037Rapid ResponseD13.5-1VF2026-10-08
10722066019044Rapid ResponseD12.49-1VAF2026-10-08
10722066018955Rapid ResponseD5.1-1VF2026-10-06
10722066018696Rapid ResponseD7.3-1VF2026-09-18
10722066018009Rapid ResponseD13.5-1VA2026-07-14
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00682607815234ON CALL® SURE BLOOD KETONE STRIPSAcon Laboratories, Inc.JIN2026-07-31
00682607815241ON CALL® SURE BLOOD KETONE STRIPSAcon Laboratories, Inc.JIN2026-07-31
00682607815258ON CALL® SURE BLOOD KETONE STRIPSAcon Laboratories, Inc.JIN2026-07-31
00682607815265ON CALL® SURE BLOOD KETONE STRIPSAcon Laboratories, Inc.JIN2026-07-31
00682607815098ON CALL® SURE GK BLOOD GLUCOSE & KETONE MONITORING SYSTEMAcon Laboratories, Inc.JIN2026-07-30
00682607815104ON CALL® SURE GK BLOOD GLUCOSE & KETONE METERAcon Laboratories, Inc.JIN2026-07-30
00682607815111ON CALL® SURE SYNC GK BLOOD GLUCOSE & KETONE MONITORING SYSTEMAcon Laboratories, Inc.JIN2026-07-30
00682607815272ON CALL® SURE KETONE CONTROL SOLUTIONAcon Laboratories, Inc.JIN2026-07-30
00860015091604KetoBMKETOBM USA LLCJIN2026-07-14
00860015091628KetoBMKETOBM USA LLCJIN2026-07-14
06935740751568Fully-Automated Urine Chemistry AnalyzerUrit Medical Electronic Co., Ltd.JIO2026-06-26
06935740751568Fully-Automated Urine Chemistry AnalyzerUrit Medical Electronic Co., Ltd.JIR2026-06-26
06935740751568Fully-Automated Urine Chemistry AnalyzerUrit Medical Electronic Co., Ltd.JMT2026-06-26
06935740751568Fully-Automated Urine Chemistry AnalyzerUrit Medical Electronic Co., Ltd.JJB2026-06-26
06935740751568Fully-Automated Urine Chemistry AnalyzerUrit Medical Electronic Co., Ltd.LJX2026-06-26
06935740751568Fully-Automated Urine Chemistry AnalyzerUrit Medical Electronic Co., Ltd.JIN2026-06-26
06935740751568Fully-Automated Urine Chemistry AnalyzerUrit Medical Electronic Co., Ltd.JIL2026-06-26
06935740751568Fully-Automated Urine Chemistry AnalyzerUrit Medical Electronic Co., Ltd.CEN2026-06-26
06935740751568Fully-Automated Urine Chemistry AnalyzerUrit Medical Electronic Co., Ltd.CDM2026-06-26
06935740751575Urine Chemistry StripsUrit Medical Electronic Co., Ltd.LJX2026-06-26
06935740751575Urine Chemistry StripsUrit Medical Electronic Co., Ltd.JMT2026-06-26
06935740751575Urine Chemistry StripsUrit Medical Electronic Co., Ltd.JJB2026-06-26
06935740751575Urine Chemistry StripsUrit Medical Electronic Co., Ltd.JIR2026-06-26
06935740751575Urine Chemistry StripsUrit Medical Electronic Co., Ltd.JIN2026-06-26
06935740751575Urine Chemistry StripsUrit Medical Electronic Co., Ltd.JIL2026-06-26
06935740751575Urine Chemistry StripsUrit Medical Electronic Co., Ltd.CEN2026-06-26
06935740751575Urine Chemistry StripsUrit Medical Electronic Co., Ltd.CDM2026-06-26
06935740751575Urine Chemistry StripsUrit Medical Electronic Co., Ltd.JIO2026-06-26
06972164410022LOOKEE® AscleTrack™ Urine Microalbumin (MAU) Test StripKunming Lianen Biotechnology Co., LTDJIR2026-06-26
06935740751773Urine StripsUrit Medical Electronic Co., Ltd.JMT2026-06-03