FDA.reportPublic FDA data

MR Detergent Solution

Primary DI
06936415904678
Brand
MR Detergent Solution
Company
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Model
105-011383-00
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
06936415904678PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06936415904678069364159046786936415904678

GMDN Terms#

Term, Definition table
TermDefinition
Buffered sample diluent IVDA buffered diluent solution intended to be used as a consumable reagent during manual procedures or on-board an automated or semi-automated instrument (e.g., haematological cell analyser) for the processing, staining and/or testing of clinical laboratory specimens (e.g., whole blood).

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
06936415904661MR Na/K Check Solution105-011386-002026-01-23
06936415904685MR Buffer Solution105-011382-002026-01-23
06944904084459Chemistry AnalyzerCLC720i2026-01-23
06903053010641M-30CFL LYSEM-30CFL105-026307-002026-01-22
06936415908805M-30CFL LYSEM-30CFL105-006209-002026-01-22
06936415908812M-30CFL LYSEM-30CFL105-006210-002026-01-22
06936415994457PROBE CLEANSERPROBE CLEANSER105-009432-002026-01-22
06944904030210PROBE CLEANSERPROBE CLEANSER105-002225-002026-01-22
06944904093116M-5LEO(I) LyseM-5LEO(I)105-011724-002026-01-22
06944904093123M-5LEO(I) LyseM-5LEO(I)105-011725-002026-01-22
06944904093130M-5LEO(II) LyseM-5LEO(II)105-011729-002026-01-22
06944904093147M-5LEO(II) LyseM-5LEO(II)105-011730-002026-01-22
06944904093154M-53LH LYSEM-53LH105-011734-002026-01-22
06944904093161M-53LH LYSEM-53LH105-011735-002026-01-22
06936415973643VS 9 Vital Signs MonitorVS 92025-01-24
06936415973650VS 8 Vital Signs MonitorVS 82025-01-24
06936415973667VS 8A Vital Signs MonitorVS 8A2025-01-24
06936415972417BeneVision Central Monitoring SystemBeneVision2024-09-24
06944904055152BeneVision Central Monitoring SystemBeneVision115-034413-002015-10-20
06944904055275BeneVision Central Monitoring SystemBeneVision115-034410-002015-10-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
06936415904685MR Buffer 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
10739470000179Micro-Scientific MicroKleen LSMICRO-SCIENTIFIC, LLCJCB2025-04-29
50739470400168Micro-Scientific Enzyclean IVMICRO-SCIENTIFIC, LLCJCB2025-04-29
06903053010658M-30RShenzhen Mindray Bio-Medical Electronics Co., Ltd.JCB2025-01-17