FDA.reportPublic FDA data

Atellica DT Solution 2 (S2)

Primary DI
45999883586752
Brand
Atellica DT Solution 2 (S2)
Company
Diatron Medicinai Instrumentumok Laboratoriumi Diagnosztikai Fejleszto-Gyarto Zartkoruen Mukodo Reszvenytarsasag
Model
Atellica DT Solution 2 (S2)
Catalog number
11310508
Device description
Atellica DT Solution 2 (S2) contains detergents, for regular cleaning and rinsing of Atellica DT 250 Analyzer’s probes, cuvettes, and tubings removing reagents, samples and protein deposits.
Published
2025-04-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
JCBDetergent

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JCBDetergentPathology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
55999883586759PackageGS16In Commercial Distribution
45999883586752PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5599988358675955999883586759
4599988358675245999883586752

GMDN Terms#

Term, Definition table
TermDefinition
Wash/cleaning solution IVD, automated/semi-automated systemA concentrated wash or cleaning solution intended to be used as a consumable reagent on-board an automated or semi-automated instrument that is used for the processing, staining and/or testing of clinical laboratory specimens.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature4 Degrees Celsius32 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
+872293711contact@siemens-healthineers.com

Regulatory Flags#

DUNS number
427395277
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
05999860094180Pictus 700 clinilcal chemistry analyzerPictus 700 clinilcal chemistry analyzer with ISEP700-32018-06-26
05999883586884Pictus 700 clinilcal chemistry analyzer Pictus 700 clinilcal chemistry analyzer W/out ISE P700-12018-06-26
05999883586891Pictus 400 Clinical chemistry analyzerPictus 400 clinical chemistry analyzer W/out ISE P400-12018-06-26
25999860094153Trigger Solutions Pack226491-TRP2026-01-05
159998600941705x TBS Wash BufferTWB562025-12-11
059998600941735x TBS Wash BufferTWB562025-12-11
05999860094227Pictus 400 Clinical chemistry analyzerPictus 400 clinical chemistry analyzer with barcodP400-32018-06-26
05999860094234Pictus 400 Clinical chemistry analyzerPictus 400 clinical chemistry analyzer with ISE anP400-42018-06-26
05999883586686NA ELECTRODE, ISE MODULENA+ Electrode52012016-10-06
05999883586709CL ELECTRODE, ISE MODULECl- Electrode52032016-10-06
05999883586693K ELECTRODE, ISE MODULEK+ Electrode52022016-10-06
05999883586419P780 Clinical Chemistry Analyzer with ISE moduleP780 Clinical Chemistry Analyzer with ISE moduleP780-12025-07-10
05999883586426P780 Clinical Chemistry AnalyzerP780 Clinical Chemistry AnalyzerP780-22025-07-10
05999883586907Atellica DT Cuvettes (280pcs)Atellica DT Cuvettes (280pcs)113105122025-06-13
15999883586751Atellica DT Solution 1 (S1)Atellica DT Solution 1 (S1)113105072025-04-30
15999883586867Atellica DT Solution 4 (S4)Atellica DT Solution 4 (S4)113105102025-04-30
05999883586747Atellica DT 250 Analyzer Atellica DT 250113105042025-04-30
15999883586744Atellica DT 250 Analyzer Atellica DT 250113105042025-04-30
25999883586758Atellica DT Solution 1 (S1)Atellica DT Solution 1 (S1)113105072025-04-30
15999883586850Atellica DT Solution 3 (S3)Atellica DT Solution 3 (S3)113105052025-04-30

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
06936415904678MR Detergent SolutionShenzhen Mindray Bio-Medical Electronics Co., Ltd.JCB2026-01-23
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
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