FDA.reportPublic FDA data

DRI pH-Detect pH 11.5 Control Kit

Primary DI
00884883005495
Brand
DRI pH-Detect pH 11.5 Control Kit
Company
Microgenics Corporation
Model
100281
Published
2018-01-05
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
JQYPh Meter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JQYPh MeterClinical Chemistry1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K952178000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K952178000PH-DETECT TESTDiagnostic Reagents, Inc.1995-10-20JQY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00884883005495PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00884883005495008848830054958848830054950884883005495

GMDN Terms#

Term, Definition table
TermDefinition
Urine pH 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 pH 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
122153799
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00884883009080MAS Immunology Advanced Sample PackICA-S12026-05-27
00884883011373MAS Immunology Advanced Level 1ICA-1012026-05-27
00884883011380MAS Immunology Advanced Level 2ICA-2022026-05-27
00884883011397MAS Immunology Advanced Level 3ICA-3032026-05-27
00884883011427CRP (C-Reactive Protein)75-54422026-05-27
00884883006751DRI Ecstasy Plus Assay100246312018-09-27
00884883001558CEDIA Heroin Metabolite (6-AM) Assay1001072016-09-26
00884883004245CEDIA Heroin Metabolite (6-AM) Assay1001082016-09-22
00884883004306CEDIA Heroin Metabolite (6-AM) Assay1001862016-09-21
00884883011366CEDIA Heroin Metabolite (6-AM) Assay100152132016-09-21
00884883009301MAS Omni•IMMUNE Max, Level 1OIMM-1012025-08-12
00884883009318MAS Omni•IMMUNE Max, Level 2OIMM-2022025-08-12
00884883009325MAS Omni•IMMUNE Max, Level 3OIMM-3032025-08-12
00884883009332MAS Omni•IMMUNE Max, Sample PackOIMM-SP2025-08-12
00884883009349MAS Omni•IMMUNE PRO Max, Level 1OPROM-1012025-08-12
00884883009356MAS Omni•IMMUNE PRO Max, Level 2OPROM-2022025-08-12
00884883009363MAS Omni•IMMUNE PRO Max, Level 3OPROM-3032025-08-12
00884883009370MAS Omni•IMMUNE PRO Max, Sample PackOPROM-SP2025-08-12
00884883009257MAS OmniCORE Max, Level 1OCRM-1012025-06-27
00884883009264MAS OmniCORE Max, Level 2OCRM-2022025-06-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00817302024319CAROLINA LIQUID CHEMISTRIES CORP.® PH REAGENT REAGENT KIT CC447CAROLINA LIQUID CHEMISTRIES CORPORATIONJQY2022-08-19
00884883005518DRI pH-Detect pH 3.0 and 11.0 Calibrator KitMicrogenics CorporationJQY2018-02-06
00884883011663DRI pH-Detect TestMicrogenics CorporationJQY2018-02-06
00884883005501DRI pH-Detect pH 3.6 Control KitMicrogenics CorporationJQY2018-01-05
00884883005525DRI pH-Detect pH 7.0 Control KitMicrogenics CorporationJQY2017-10-30
00884883005532DRI pH-Detect 10.0 Control KitMicrogenics CorporationJQY2017-10-18
00884883002999DRI pH DetectMicrogenics CorporationJQY2017-04-28