Atellica™ IM Fol

Primary DI
00630414598970
Brand
Atellica™ IM Fol
Company
Siemens Healthcare Diagnostics Inc.
Model
10995573
Catalog number
10995573
Device description
Folic Acid (Fol) - Atellica IM - RGT - 700T
Published
2018-06-05
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
CGNACID, FOLIC, RADIOIMMUNOASSAY

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CGNAcid, Folic, RadioimmunoassayClinical Chemistry2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K172201000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K172201000Atellica IM Folate AssaySiemens Healthcare Diagnostics, Inc.2018-04-12CGN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00630414598970PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00630414598970006304145989706304145989700630414598970

GMDN Terms#

Term, Definition table
TermDefinition
Folate (vitamin B9) IVD, kit, chemiluminescent immunoassayA collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of folate (vitamin B9) in a clinical specimen, using a chemiluminescent immunoassay method.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store Upright, Protect from Light, Do not freeze, Resuspend.
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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Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00816870020327Folate AccuBind ELISA Test System - 96 WellsMONOBIND, INC.CGN2019-02-11
00816870020334Monobind AccuBind Folate ELISA Kit - 192 WellsMONOBIND, INC.CGN2019-02-11
00816870022000Folate AccuLite CLIA Test System - 96 WellsMONOBIND, INC.CGN2019-02-11
00816870022017Folate AccuLite CLIA Test System -192 WellsMONOBIND, INC.CGN2019-02-11
00630414469454ADVIA Centaur® FOL (25-pack)Siemens Healthcare Diagnostics Inc.CGN2018-12-01
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