FDA.reportPublic FDA data

Atellica IM AB12

Primary DI
00630414245720
Brand
Atellica IM AB12
Company
Siemens Healthcare Diagnostics Inc.
Model
10733001
Catalog number
10733001
Device description
Active-B12 (AB12) Atellica IM - RGT 100T
Published
2018-10-19
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
CDDRADIOASSAY, VITAMIN B12

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CDDRadioassay, Vitamin B12Clinical Chemistry2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K160757000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K160757000ADVIA Centaur Active-B12 (Holotranscobalamin)(AB12) Assay, ADVIA Centaur Active-B12(AB12) Quality Control, and ADVIA Centaur Active-B12 (AB12) Master Curve Materials (MCM)Axis-Shield Diagnostics Limited2016-07-26CDD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00630414245720PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00630414245720006304142457206304142457200630414245720

GMDN Terms#

Term, Definition table
TermDefinition
Holotranscobalamin (holoTC) IVD, kit, chemiluminescent immunoassayA collection of reagents and other associated materials intended to be used for the quantitative measurement of holotranscobalamin (holoTC), also known as active-B12, in a clinical specimen, using a chemiluminescent immunoassay. It is used to aid in the diagnosis and treatment of vitamin B12 deficiency.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling 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
Manufacturing date on label
true
Expiration date on label
true

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00630414513102ADVIA® Chemistry CA_2 Calcium_2 Reagents (Arsenazo III)10341116103411162016-09-24
00630414517742ADVIA® Chemistry C4 Complement C4 Reagents10309054103090542016-09-24
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00630414465401ADVIA® Chemistry CHE Cholinesterase Reagents10329639103296392020-09-24
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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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00380740189808ARCHITECTAbbott GmbHCDD2026-01-01
00380740189815AlinityAbbott GmbHCDD2026-01-01
15099590224301Access Vitamin B12Beckman Coulter, Inc.CDD2025-09-09
00630414600307Atellica IM VB12 MCMSiemens Healthcare Diagnostics Inc.CDD2020-09-24
00630414293554Atellica IM Calibrator CSiemens Healthcare Diagnostics Inc.CDD2020-05-31
00630414293820Atellica IM VB12Siemens Healthcare Diagnostics Inc.CDD2020-05-31
00630414294100Atellica IM Calibrator CSiemens Healthcare Diagnostics Inc.CDD2020-05-31
00630414294261Atellica IM VB12Siemens Healthcare Diagnostics Inc.CDD2020-05-31
08056771602532LIAISON® Vitamin B12Diasorin Inc.CDD2019-12-04
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00816870021966Folate, Vit B12 Anemia Panel AccuLite VAST CLIA Test System - 96 WellsMONOBIND, INC.CDD2019-02-11
00816870021973Monobind AccuLite Folate & Vit B12 VAST CLIA Kit - 192 WellsMONOBIND, INC.CDD2019-02-11
00816870022048Vit B12 AccuLite CLIA Test System - 96 WellsMONOBIND, INC.CDD2019-02-11
00816870022055Vit B12 AccuLite CLIA Test System - 192 WellsMONOBIND, INC.CDD2019-02-11
00380740136703AlinityABBOTT IRELANDCDD2019-01-02
00380740136697AlinityABBOTT IRELANDCDD2018-11-12
00630414598611Atellica IM CKMB MCMSiemens Healthcare Diagnostics Inc.CDD2018-02-06
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