FDA.reportPublic FDA data

Atellica CH Gamma-Glutamyl Transferse 2 (GGT_2)

Primary DI
00630414313382
Brand
Atellica CH Gamma-Glutamyl Transferse 2 (GGT_2)
Company
Siemens Healthcare Diagnostics Inc.
Model
11537248
Catalog number
11537248
Device description
Gamma-Glutamyl Transferase (GGT_2) Reagents
Published
2024-02-02
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
JQBKINETIC METHOD, GAMMA-GLUTAMYL TRANSPEPTIDASE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JQBKinetic Method, Gamma-Glutamyl TranspeptidaseClinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00630414628707PrimaryGS10
00630414313382Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00630414628707006304146287076304146287070630414628707
00630414313382006304143133826304143133820630414313382

GMDN Terms#

Term, Definition table
TermDefinition
Gamma-glutamyltransferase (GGT) IVD, kit, spectrophotometryA collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of gamma glutamyltransferase (GGT) in a clinical specimen, using a spectrophotometry method.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature2 Degrees Celsius8 Degrees Celsius
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(877)229-3711CONTACT@SIEMENS-HEALTHINEERS.COM

Regulatory Flags#

DUNS number
064608573
Device count
4
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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10673486001839Teco Diagnostics g-Glutamyl Transferase Reagent Set (Kinetic, Soluble Substrate)TECO DIAGNOSTICSJQB2023-11-06
10673486001846Teco Diagnostics g-Glutamyl Transferase Reagent Set (Kinetic, Soluble Substrate)TECO DIAGNOSTICSJQB2023-11-06
10673486001853Teco Diagnostics g-Glutamyl Transferase (GGT) Liquid Reagent Set (Kinetic)TECO DIAGNOSTICSJQB2023-11-06
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