FDA.reportPublic FDA data

Atellica IM VB12 DIL

Primary DI
00630414600291
Brand
Atellica IM VB12 DIL
Company
Siemens Healthcare Diagnostics Inc.
Model
10995716
Catalog number
10995716
Device description
Vitamin B12 (VB12) Diluent Atellica IM - CONS (2PK) 2 x 5mL
Published
2018-02-06
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
K993571000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K993571000BAYER DIAGNOSTICS ACS:180 VB12, BAYER DIAGNOSTICS ADVIA CENTAUE VB12Bayer Corp.1999-12-16CDD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00630414600291PrimaryGS10
00630414007908Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00630414600291006304146002916304146002910630414600291
00630414007908006304140079086304140079080630414007908

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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Primary DI, Brand, Company table
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00380740136703AlinityABBOTT IRELANDCDD2019-01-02
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