Atellica CH GluH_3

Primary DI
00630414596488
Brand
Atellica CH GluH_3
Company
Siemens Healthcare Diagnostics Inc.
Model
11097592
Catalog number
11097592
Device description
Glucose Hexokinase ( GluH_3) Atellica CH - RGT 6240T
Published
2017-12-22
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
CFRHEXOKINASE, GLUCOSE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CFRHexokinase, GlucoseClinical Chemistry2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K101854000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K101854000ADVIA CHEMISTRY GLUCOSE HEXOKINASE_3 (GLUH_3) REAGENT, MODELS REF 05001429Siemens Healthcare Diagnostics2011-03-07CFR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00630414596488PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00630414596488006304145964886304145964880630414596488

GMDN Terms#

Term, Definition table
TermDefinition
Glucose IVD, kit, enzyme spectrophotometryA collection of reagents and other associated materials intended to be used for the quantitative measurement of glucose in a clinical specimen, using an enzyme spectrophotometry method.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
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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