FDA.reportPublic FDA data

ADVIA® 120/2120/2120i CBC TIMEpac

Primary DI
00630414222882
Brand
ADVIA® 120/2120/2120i CBC TIMEpac
Company
Siemens Healthcare Diagnostics Inc.
Model
10312269
Catalog number
T01-3620-52
Device description
ADVIA®120/2120/2120i CBCTIMEPAC®
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
GKLCOUNTER, CELL, AUTOMATED (PARTICLE COUNTER)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GKLCounter, Cell, Automated (Particle Counter)Hematology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K971998000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K971998000ADVIA 120 HEMATOLOGY SYSTEM, IN VITRO DIAGNOSTIC SYSTEMBayer Corp.1997-08-29GKL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00630414222882PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00630414222882006304142228826304142228820630414222882

GMDN Terms#

Term, Definition table
TermDefinition
Full blood count IVD, kit, cell countA collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative determination of one or multiple whole blood cell parameters [also known as complete blood count (CBC)] in a clinical specimen using a manual, semi-automated or automated cell count method. Test components may include white cell count and differential, haemoglobin determination, red cell count, red cell characterization and calculation of red cell parameters, and/or platelet count.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Protect from freezing
Storage Environment Temperature15 Degrees Celsius25 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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