FDA.reportPublic FDA data

NA

Primary DI
00848838023835
Brand
NA
Company
REMEL, INC.
Model
R21526
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
JIOBlood, Occult, Colorimetric, In Urine

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JIOBlood, Occult, Colorimetric, In UrineHematology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K913005000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K913005000BACTIDROP(TM) LACTOPHENOL ANILINE BLUERemel Co.1991-09-16JIO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00848838023835PrimaryGS10
00848838099847Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00848838023835008488380238358488380238350848838023835
00848838099847008488380998478488380998470848838099847

GMDN Terms#

Term, Definition table
TermDefinition
Aniline blue solution IVDAn aniline blue solution intended to be used alone, or in combination with other solutions/stains, for the visualization of biological/clinical specimen tissue structures and/or intra/extracellular elements.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
8002556730ITechnicalSupport@remel.com

Regulatory Flags#

DUNS number
065769564
Device count
50
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00848838018855NACP114-102016-09-24
00848838031274REMELR40041R400412023-01-03
00842558116709Spectra™ Candida Agar R018332026-02-09
00848838072772MicroTest M6R12582R125822022-12-22
00848838074844MicroTest M4RTR12567R125672022-12-22
00848838075018MicroTest M6R12560R125602022-12-22
00848838091827NA7115-602022-04-21
00848838091742VersaTREK™ VersaTREK™ Myco Streptomycin, 7120-302025-01-16
00848838091834NA7116-702016-12-09
00848838003158Strep Selective II AgarR018592026-01-16
00848838059865^BM^ PK/50 OXIDASE TESTR90556352026-01-16
00848838066856Liquid Amies,Dual Swab PK/50R7230952025-06-18
00848838066887Liquid Stuarts,Single Swab PK/500R7231102025-06-18
00848838066894Liquid Stuarts,Single Swab PK/50R7231152025-06-18
00848838066900Liquid Stuarts,Dual Swab PK/500R7231202025-06-18
00848838066917Liquid Stuarts,Dual Swab PK/50R7231252025-06-18
00848838066924Liquid Stuarts,Wire Shaft Swab PK/100R7231302025-06-18
00848838066931Liquid Stuarts,Wire Shaft PK/50R7231352025-06-18
00848838011177Sensititre Demineralized WaterT33392023-12-21
00842558105611^CE^Liq Stuarts,Dual Swab 36mmPK/500r97231202025-10-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06935740750608Urine Reagent StripsUrit Medical Electronic Co., Ltd.JIO2026-04-16
06935740750615Urine Reagent StripsUrit Medical Electronic Co., Ltd.JIO2026-04-16
06935740750738Automatic Urine AnalyzerUrit Medical Electronic Co., Ltd.JIO2026-04-16
20682607200485Mission U120 Smart Urine AnalyzerAcon Laboratories, Inc.JIO2026-02-06
20682607200492Mission U120 Smart Urine AnalyzerAcon Laboratories, Inc.JIO2026-02-06
20682607200904Mission U120 Touch Urine AnalyzerAcon Laboratories, Inc.JIO2026-02-06
20682607200911Mission U120 Touch Urine AnalyzerAcon Laboratories, Inc.JIO2026-02-06
10612479279886MckessonMCKESSON MEDICAL-SURGICAL INC.JIO2025-09-18
00850054026729QMedix™Diagnostic Automation, Inc.JIO2024-10-29
06935740733755Automatic Urine AnalyzerUrit Medical Electronic Co., Ltd.JIO2024-06-14
10673486000528Teco Diagnostics TC-Thunderbolt Automated Urine Analyzer SystemTECO DIAGNOSTICSJIO2024-06-06
10673486000498Teco Diagnostics Uritek TC-720+ Urine Chemistry Test SystemTECO DIAGNOSTICSJIO2024-06-05
10673486000511Teco Diagnostics Uritek TC-201 Urine Chemistry Test SystemTECO DIAGNOSTICSJIO2024-06-04
00657498002094Uri-Trak 120 M Urine AnalyzerSTANBIO LABORATORY, L.P.JIO2023-06-08
40612479183627McKessonMCKESSON MEDICAL-SURGICAL INC.JIO2022-07-28
10884389181973MedlineMEDLINE INDUSTRIES, INC.JIO2022-04-13
10884389181959MedlineMEDLINE INDUSTRIES, INC.JIO2021-09-16
00722066005255Rapid ResponseBTNX IncJIO2020-12-14
08806141302209Just Fitter 10 Parameter Test Strips DFI CO.,LTDJIO2020-09-22
10888277110403MedlineMEDLINE INDUSTRIES, INC.JIO2020-08-21
10885380175589CARDINAL HEALTHCardinal Health 200, LLCJIO2020-07-09
20885380175548CARDINAL HEALTHCardinal Health 200, LLCJIO2020-06-30
20885380175555CARDINAL HEALTHCardinal Health 200, LLCJIO2020-06-30
20885380175579CARDINAL HEALTHCardinal Health 200, LLCJIO2020-06-30
08806141302070CYBOW 10DFI CO.,LTDJIO2020-06-29
10673486000672TECO DIAGNOSTICSTECO DIAGNOSTICSJIO2020-03-09
08806141301998Yodoc 10DFI CO.,LTDJIO2020-02-20
00722066001219Rapid ResponseBTNX IncJIO2019-10-16
00722066001936Rapid ResponseBTNX IncJIO2019-10-16
06945040104780CONTECContec Medical Systems Co., Ltd.JIO2019-09-10