FDA.reportPublic FDA data

MR Buffer Solution

Primary DI
06936415904685
Brand
MR Buffer Solution
Company
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Model
105-011382-00
Published
2026-01-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe

Product Codes#

Code, Name table
CodeName
JCBDetergent

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JCBDetergentPathology1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K160370000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K160370000BS-800M/ ABS800/BA-800M ISE KIT, BS-800M Chemistry Analyzer, BA-800M Chemistry Analyzer, ABS800 Chemistry AnalyzerShenzhen Mindray Bio-Medical Electronics Co., Ltd.2016-06-09JGS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06936415904685PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06936415904685069364159046856936415904685

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
654671304
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06903053063852Diagnostic Ultrasound SystemImagyn A20 Exp2026-10-31
06903053063869Diagnostic Ultrasound SystemNuewa A20Q2026-10-31
06903053063876Diagnostic Ultrasound SystemNuewa A Lumi2026-10-31
06903053063883Diagnostic Ultrasound SystemNuewa A18W2026-10-31
06903053063890Diagnostic Ultrasound SystemNuewa A20 Exp2026-10-31
06903053063906Diagnostic Ultrasound SystemNuewa A20 Plus2026-10-31
06903053063913Diagnostic Ultrasound SystemNuewa A20 Elite2026-10-31
06903053063937Diagnostic Ultrasound SystemNuewa AR2026-10-31
06903053063944Diagnostic Ultrasound SystemNuewa A202026-10-31
06903053063951Diagnostic Ultrasound SystemNuewa A MS2026-10-31
06903053063968Diagnostic Ultrasound SystemImagyn A20S2026-10-31
06903053063975Diagnostic Ultrasound SystemNuewa A20S2026-10-31
06903053063982Diagnostic Ultrasound SystemNuewa A20 Premium2026-10-31
06903053064002Diagnostic Ultrasound SystemNuewa A20W2026-10-31
06903053064019Diagnostic Ultrasound SystemNuewa A20 Pro2026-10-31
06903053064026Diagnostic Ultrasound SystemNuewa A MV2026-10-31
06903053064033Diagnostic Ultrasound SystemImagyn A202026-10-31
06903053064040Diagnostic Ultrasound SystemNuewa A20T2026-10-31
06903053064057Diagnostic Ultrasound SystemNuewa A Elite2026-10-31
06903053064064Diagnostic Ultrasound SystemImagyn A20T2026-10-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06978139074091Probe Rinse SolutionShenzhen Lifotronic Technology Co.,Ltd.JCB2026-11-03
06935740751599Detergent Ready to UseUrit Medical Electronic Co., Ltd.JCB2026-06-26
06935740751674Detergent ConcentratedUrit Medical Electronic Co., Ltd.JCB2026-06-26
06935740750622Detergent for Automatic Urine AnalyzerUrit Medical Electronic Co., Ltd.JCB2026-04-16
06935740750639Detergent for Automatic Urine AnalyzerUrit Medical Electronic Co., Ltd.JCB2026-04-16
06935740750646Detergent for Automatic Urine AnalyzerUrit Medical Electronic Co., Ltd.JCB2026-04-16
08436583731888Grifols Wash Solution ADIAGNOSTIC GRIFOLS SAJCB2026-03-13
08436583731895Grifols Wash Solution BDIAGNOSTIC GRIFOLS SAJCB2026-03-13
06936415904678MR Detergent SolutionShenzhen Mindray Bio-Medical Electronics Co., Ltd.JCB2026-01-23
06936415994457PROBE CLEANSERShenzhen Mindray Bio-Medical Electronics Co., Ltd.JCB2026-01-22
06944904030210PROBE CLEANSERShenzhen Mindray Bio-Medical Electronics Co., Ltd.JCB2026-01-22
159998600941705x TBS Wash BufferDiatron Medicinai Instrumentumok Laboratoriumi Diagnosztikai Fejleszto-Gyarto Zartkoruen Mukodo ReszvenytarsasagJCB2025-12-11
059998600941735x TBS Wash BufferDiatron Medicinai Instrumentumok Laboratoriumi Diagnosztikai Fejleszto-Gyarto Zartkoruen Mukodo ReszvenytarsasagJCB2025-12-11
15999883586751Atellica DT Solution 1 (S1)Diatron Medicinai Instrumentumok Laboratoriumi Diagnosztikai Fejleszto-Gyarto Zartkoruen Mukodo ReszvenytarsasagJCB2025-04-30
15999883586867Atellica DT Solution 4 (S4)Diatron Medicinai Instrumentumok Laboratoriumi Diagnosztikai Fejleszto-Gyarto Zartkoruen Mukodo ReszvenytarsasagJCB2025-04-30
45999883586752Atellica DT Solution 2 (S2)Diatron Medicinai Instrumentumok Laboratoriumi Diagnosztikai Fejleszto-Gyarto Zartkoruen Mukodo ReszvenytarsasagJCB2025-04-30
25999883586758Atellica DT Solution 1 (S1)Diatron Medicinai Instrumentumok Laboratoriumi Diagnosztikai Fejleszto-Gyarto Zartkoruen Mukodo ReszvenytarsasagJCB2025-04-30
15999883586850Atellica DT Solution 3 (S3)Diatron Medicinai Instrumentumok Laboratoriumi Diagnosztikai Fejleszto-Gyarto Zartkoruen Mukodo ReszvenytarsasagJCB2025-04-30
25999883586864Atellica DT Solution 4 (S4)Diatron Medicinai Instrumentumok Laboratoriumi Diagnosztikai Fejleszto-Gyarto Zartkoruen Mukodo ReszvenytarsasagJCB2025-04-30
55999883586759Atellica DT Solution 2 (S2)Diatron Medicinai Instrumentumok Laboratoriumi Diagnosztikai Fejleszto-Gyarto Zartkoruen Mukodo ReszvenytarsasagJCB2025-04-30
00739470000011Micro-Scientific Enzyclean IIMICRO-SCIENTIFIC, LLCJCB2025-04-29
00739470000028Micro-Scientific EnzycleanMICRO-SCIENTIFIC, LLCJCB2025-04-29
00739470000066Micro-Scientific MicroKleen HSMICRO-SCIENTIFIC, LLCJCB2025-04-29
00739470000158Micro-Scientific Enzyclean II LSMICRO-SCIENTIFIC, LLCJCB2025-04-29
00739470000172Micro-Scientific MicroKleen LSMICRO-SCIENTIFIC, LLCJCB2025-04-29
00739470400163Micro-Scientific Enzyclean IVMICRO-SCIENTIFIC, LLCJCB2025-04-29
10739470000018Micro-Scientific Enzyclean IIMICRO-SCIENTIFIC, LLCJCB2025-04-29
10739470000025Micro-Scientific EnzycleanMICRO-SCIENTIFIC, LLCJCB2025-04-29
10739470000063Micro-Scientific MicroKleen HSMICRO-SCIENTIFIC, LLCJCB2025-04-29
10739470000155Micro-Scientific Enzyclean II LSMICRO-SCIENTIFIC, LLCJCB2025-04-29