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

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
00630414628707Atellica 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