FDA.reportPublic FDA data

Atellica CH Gamma-Glutamyl Transferse 2 (GGT_2)

Primary DI
00630414628707
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

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

Contacts#

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

Regulatory Flags#

DUNS number
064608573
Device count
4
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00630414517681ADVIA® Chemistry ASO_2 Anti-Streptolysin-O_2 Reagents1031820830554832020-09-24
00842768016912Dimension® PBNP Calibrator10445008RC423A2016-09-24
00630414498942ADVIA® Chemistry ACET Acetaminophen Reagents1032738179891382016-09-24
00630414568768ADVIA® Chemistry BENZ_2 Benzodiazepine_2 Reagents10378760103787602016-09-24
00630414611075Atellica CH Crea311537215115372152026-05-08
00630414653259Atellica CH Crea311537567115375672026-05-08
00630414618456ADVIA CENTAUR ELF MCM SET11208709112087092023-03-15
00630414506005ADVIA® Chemistry HAPT Haptoglobin Reagents103141648310082016-09-24
00630414595795Atellica CH ECre_211097533110975332017-12-22
00842768015281Dimension Vista® Flex® reagent cartridge LIDO10445132K41132016-09-24
00630414291338ADVIA Centaur Cytokeratin Fragment 21-1 (CYFRA)11354590113545902026-04-16
00630414291345Atellica IM CYFRA 21-111354591113545912026-04-16
00630414292779Siemens Healthineers CYFRA 21-1 MCM11536187115361872026-04-16
00630414292786Atellica IM CYFRA 21-1 MCM11536188115361882026-04-16
00630414611693ADVIA Centaur Cytokeratin Fragment 21-1 Calibrator (CYFRA CAL)11553956115539562026-04-16
00630414622804Atellica IM CYFRA21-1 Calibrator11553957115539572026-04-16
00630414654041Atellica CH Ca11645759116457592026-04-08
00630414654102Atellica CH ALP_2c11645758116457582026-04-08
00630414654133Atellica CH UA11645765116457652026-04-08
00630414293622Atellica IM DHEAS11206197112061972020-05-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00630414313382Atellica CH Gamma-Glutamyl Transferse 2 (GGT_2)Siemens Healthcare Diagnostics Inc.JQB2024-02-02
10673486001860Teco Diagnostics g-Glutamyl Transferase (GGT) Liquid Reagent Kit TC-Matrix-240TECO DIAGNOSTICSJQB2023-11-08
10673486001877Teco Diagnostics g-Glutamyl Transferase (GGT) Liquid Reagent Kit TC-Matrix-480TECO DIAGNOSTICSJQB2023-11-08
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
00811727016140Pointe GGT ReagentHORIBA INSTRUMENTS INCORPORATEDJQB2021-01-30
04015630916511gamma-Glutamyltransferase ver.2 Standardized against IFCC / SzaszRoche Diagnostics GmbHJQB2021-01-20
04015630925018gamma-Glutamyltransferase ver.2 Standardized against IFCC / SzaszRoche Diagnostics GmbHJQB2021-01-18
04015630926855gamma-Glutamyltransferase ver.2 Standardized against IFCC / SzaszRoche Diagnostics GmbHJQB2021-01-18
00842768014154Dimension® Flex® reagent cartridge GGTSiemens Healthcare Diagnostics Inc.JQB2020-09-24
00842768015229Dimension Vista® Flex® reagent cartridge GGTSiemens Healthcare Diagnostics Inc.JQB2020-09-24
03610230006993Yumizen C1200 GGTHORIBA ABX SASJQB2020-08-31
00811727015839Pointe GGT on BS480HORIBA INSTRUMENTS INCORPORATEDJQB2020-05-28
10758750004638VITROSORTHO-CLINICAL DIAGNOSTICS, INC.JQB2020-04-18
07613336121252Gamma-Glutamyltransferase ver.2 Standardized against IFCC / SzaszRoche Diagnostics GmbHJQB2020-03-10
00628063401093GGT AssaySEKISUI DIAGNOSTICS, LLCJQB2018-09-24
00852169008133ClearChem Diagnostics Inc. Gamma-glutamyltransferase (GGT)CLEARCHEM DIAGNOSTICS INC.JQB2018-04-30
05060500091880Synermed®INFRARED LABORATORY SYSTEMS LLCJQB2017-02-28
00812137011978GGT Reagent SetCLINICAL DIAGNOSTIC SOLUTIONS, INC.JQB2016-10-12
15099590010171AUBeckman Coulter, Inc.JQB2016-09-24
15099590020095AUBeckman Coulter, Inc.JQB2016-09-24
EABA40000031Piccolo Liver Panel PlusABAXIS, INC.JQB2016-09-23
EABA40000061Piccolo General Chemistry 6ABAXIS, INC.JQB2016-09-23
EABA40000291Piccolo General Chemistry 13ABAXIS, INC.JQB2016-09-23
EABA40000351Piccolo BioChemistry Panel PlusABAXIS, INC.JQB2016-09-23
00657498000786Gamma-GT LiquiColor®STANBIO LABORATORY, L.P.JQB2016-09-23
00657498000793Gamma-GT LiquiColor®STANBIO LABORATORY, L.P.JQB2016-09-23
00657498001691Sirrus® Gamma-GT LiquiColor®STANBIO LABORATORY, L.P.JQB2016-09-23
05060500090876Synermed®INFRARED LABORATORY SYSTEMS LLCJQB2016-09-20