FDA.reportPublic FDA data

ADVIA® Chemistry IGA_2 Reagents

Primary DI
00630414513133
Brand
ADVIA® Chemistry IGA_2 Reagents
Company
Siemens Healthcare Diagnostics Inc.
Model
10309033
Catalog number
2194102
Device description
IgA - ADVIA Chem. - RGT - 5x75 tests
Published
2016-09-24
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
CFNMETHOD, NEPHELOMETRIC, IMMUNOGLOBULINS (G, A, M)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CFNMethod, Nephelometric, Immunoglobulins (G, A, M)Immunology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K992662000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K9926620008 ADDITIONAL ASSAYS FOR THE BAYER ADVIA 1650 CHEMISTRY SYSTEMBayer Corp.2000-02-15MSJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00630414513133PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00630414513133006304145131336304145131330630414513133

GMDN Terms#

Term, Definition table
TermDefinition
Total immunoglobulin A (IgA total) IVD, kit, nephelometry/turbidimetryA collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of total immunoglobulin A (IgA total) in a clinical specimen, using a nephelometry/turbidimetry 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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00630414000510VERSANT HCV Control 2.0 Kit (LiPA)10719668107196682017-09-15
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00630414482309ADVIA® 1650 Chemistry System Ref.10309442103094422018-12-01
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Primary DI, Brand, Company table
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