FDA.reportPublic FDA data

ADVIA® Chemistry IRON_2 Iron 2 Reagents

Primary DI
00630414561974
Brand
ADVIA® Chemistry IRON_2 Iron 2 Reagents
Company
Siemens Healthcare Diagnostics Inc.
Model
10377510
Catalog number
10377510
Device description
Iron - ADVIA Chem. - RGT - 6x350 tests
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
JIYPhotometric method, iron (non-heme)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JIYPhotometric Method, Iron (Non-Heme)Clinical Chemistry1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K991576000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K991576000ADDITIONAL ASSAYS FOR THE BAYER ADVIA 1650 CHEMISTRY SYSTEMBayer Corp.1999-06-30CIX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00630414561974PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00630414561974006304145619746304145619740630414561974

GMDN Terms#

Term, Definition table
TermDefinition
Iron IVD, kit, spectrophotometryA collection of reagents and other associated materials intended to be used for the quantitative measurement of iron in a clinical specimen, using a spectrophotometry method.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Do not freeze
Storage Environment Temperature2 Degrees Celsius8 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
1
Lot or batch
true
Expiration date on label
true

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Primary DI, Brand, Model table
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00630414602875VERSANT HCV 2.0 LiPA10492004104920042017-09-15
00630414602882VERSANT HCV 2.0 LiPA10492005104920052017-09-15
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00630414517445ADVIA® Chemistry Lactate Dehydrogenase P-L (LDPL) Reagents10341129103411292016-09-24
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00380740160692ARCHITECTABBOTT IRELANDJIY2023-10-20
00380740160708ARCHITECTABBOTT IRELANDJIY2023-10-20
00380740168285AlinityABBOTT IRELANDJIY2023-10-20
00630414610849Atellica CH Iron3 (Iron3)Siemens Healthcare Diagnostics Inc.JIY2023-05-10
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00817302024128CAROLINA LIQUID CHEMISTRIES CORP.® IRON REAGENT KIT AU-618CAROLINA LIQUID CHEMISTRIES CORPORATIONJIY2022-08-19
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00817302024609CAROLINA LIQUID CHEMISTRIES CORP.® IRON REAGENT KIT ST618CAROLINA LIQUID CHEMISTRIES CORPORATIONJIY2022-08-19
04015630926947Iron Gen.2Roche Diagnostics GmbHJIY2021-06-11
00811727016188Pointe Iron ReagentHORIBA INSTRUMENTS INCORPORATEDJIY2021-01-30
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04015630925049Iron Gen.2Roche Diagnostics GmbHJIY2021-01-18
04015630928088Unsaturated Iron-Binding CapacityRoche Diagnostics GmbHJIY2021-01-18
00630414513157ADVIA® Chemistry IRON_2 ReagentsSiemens Healthcare Diagnostics Inc.JIY2020-09-24
00630414596402Atellica CH Iron_2Siemens Healthcare Diagnostics Inc.JIY2020-09-24
00842768015236Dimension Vista® Flex® reagent cartridge IRONSiemens Healthcare Diagnostics Inc.JIY2020-09-24
00842768020414Dimension® Flex® reagent cartridge IRONSiemens Healthcare Diagnostics Inc.JIY2020-09-24
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10758750000289VITROSORTHO-CLINICAL DIAGNOSTICS, INC.JIY2020-04-18
10758750009244VITROSORTHO-CLINICAL DIAGNOSTICS, INC.JIY2020-04-18
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