FDA.reportPublic FDA data

Atellica A-LYTE IMT Diluent

Primary DI
00630414595726
Brand
Atellica A-LYTE IMT Diluent
Company
Siemens Healthcare Diagnostics Inc.
Model
11099305
Catalog number
11099305
Device description
IMT Diluent Atellica CH - CONS 2 x 1.5L
Published
2020-09-24
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
JJEANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JJEAnalyzer, Chemistry (Photometric, Discrete), For Clinical UseClinical Chemistry1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K151767000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K151767000Trinidad CH system, TD-LYTE Integrated Multisensor (Na, K, CI), TD-LYTE IMT Standard A, TD-LYTE IMT Standard B + Salt Bridge, Trinidad CH Albumin BCP reagent (Alb_P), Trinidad CH Albumin BCP CalibratorSiemens Healthcare Diagnostics, Inc.2015-12-11JGS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00630414595726PrimaryGS10
00630414006932Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00630414595726006304145957266304145957260630414595726
00630414006932006304140069326304140069320630414006932

GMDN Terms#

Term, Definition table
TermDefinition
Buffered sample diluent IVD, automated/semi-automated systemA buffered diluent solution intended to be used as a consumable reagent on-board an automated or semi-automated instrument during the processing, staining and/or testing of clinical laboratory specimens. Some types may, in addition be used for manual procedures.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(877)229-3711XX@XX.XX
+1(877)229-3711CONTACT@SIEMENS-HEALTHINEERS.COM

Regulatory Flags#

DUNS number
064608573
Device count
2
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00842768004872Dimension® TACR Calibrator10445012104450122016-09-24
00842768018312Dimension® Flex® reagent cartridge TACR10444938104449382016-09-24
00630414000497VERSANT HCV 2.0 LiPA10719666107196662017-09-15
00630414000503VERSANT HCV 2.0 LiPA10719667107196672017-09-15
00630414177021ADVIA Centaur® TSH10309958103099582016-09-24
00630414177038ADVIA Centaur® TSH10309959103099592016-09-24
00630414556093ADVIA Centaur® SHBG Calibrator10285318102853182016-09-24
00630414559704ADVIA Centaur® T3 MCM10361928103619282016-09-24
00630414574516ADVIA® Chemistry Hemoglobin A1c_3 Calibrators10491408104914082016-09-24
00630414579160ADVIA Centaur® iPTH10492369104923692016-09-24
00630414585345ADVIA Centaur® iPTH10493615104936152016-09-24
00630414585352ADVIA Centaur® iPTH10493616104936162016-09-24
00630414587486ADVIA Centaur® iPTH Calibrator10630628106306282016-09-24
00630414587882ADVIA Centaur® Systems VitD Calibrator10630911106309112016-09-24
00630414600611ADVIA® Chemistry Alkaline Phosphatase (ALP_2c) Reagents10916067109160672016-09-24
00630414596167Atellica CH ASO_211097634110976342020-09-24
00630414596259Atellica CH PreAlb11097617110976172020-09-24
00630414596440Atellica CH GGT11097597110975972020-09-24
00630414596174Atellica CH hsCRP11097633110976332017-12-21
00630414596198Atellica CH CRP_211097631110976312017-12-27

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