Atellica™ IM Fol DIL

Primary DI
00630414598987
Brand
Atellica™ IM Fol DIL
Company
Siemens Healthcare Diagnostics Inc.
Model
10995574
Catalog number
10995574
Device description
Folic Acid Diluent - Atellica IM - CONS - (2 PK) 2 x 10mL
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
00630414598987PrimaryGS10
00630414007526Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00630414598987006304145989876304145989870630414598987
00630414007526006304140075266304140075260630414007526

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
Special Storage Condition, Specify00Store upright
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
2
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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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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00380740136550AlinityABBOTT IRELANDCGN2018-11-12
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00817830022542SimulTRAC-S Vitamin B12/Folate 125I RIA KitMP BIOMEDICALS, LLCCGN2016-10-20
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04560189211926AIA-PACK Folate Calibrator SetTOSOH CORPORATIONCGN2016-09-24
04560189211933AIA-PACK Folate Pretreatment SetTOSOH CORPORATIONCGN2016-09-24
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