FDA.reportPublic FDA data

Atellica CH UN_c

Primary DI
00630414654119
Brand
Atellica CH UN_c
Company
Siemens Healthcare Diagnostics Inc.
Model
11645766
Catalog number
11645766
Device description
Urea Nitrogen (UN_c) Atellica CH - RGT 3120T
Published
2026-03-18
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
CDQUREASE AND GLUTAMIC DEHYDROGENASE, UREA NITROGEN

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CDQUrease And Glutamic Dehydrogenase, Urea NitrogenClinical Chemistry2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K991576000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K991576000ADDITIONAL ASSAYS FOR THE BAYER ADVIA 1650 CHEMISTRY SYSTEMBayer Corp.1999-06-30CIX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00630414654119PrimaryGS10
00630414322179Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00630414654119006304146541196304146541190630414654119
00630414322179006304143221796304143221790630414322179

GMDN Terms#

Term, Definition table
TermDefinition
Urea IVD, kit, spectrophotometryA collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of urea or urea nitrogen [also known as blood urea nitrogen (BUN)] in a clinical specimen, using a spectrophotometry method. It is typically used as an indicator of kidney function and/or to differentiate between prerenal and postrenal azotemia.

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
2
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
06944904084459Chemistry AnalyzerShenzhen Mindray Bio-Medical Electronics Co., Ltd.CDQ2026-01-23
10673486013580Teco Diagnostics TC Matrix Clinical Chemistry AnalyzerTECO DIAGNOSTICSCDQ2025-05-28
10673486013726Teco Diagnostics TC Matrix Clinical Chemistry AnalyzerTECO DIAGNOSTICSCDQ2025-05-28
10673486013894Teco Diagnostics TC Matrix Clinical Chemistry AnalyzerTECO DIAGNOSTICSCDQ2025-05-28
10673486013962Teco Diagnostics TC Matrix Clinical Chemistry AnalyzerTECO DIAGNOSTICSCDQ2025-05-28
00850053916069IDG/SanzayIDG/SANZAY CorporationCDQ2024-01-09
10673486001228Teco Diagnostics Urea Nitrogen (BUN) Liquid Reagent SetTECO DIAGNOSTICSCDQ2023-07-21
10673486001235Teco Diagnostics BUN (Urea) Reagent Kit TC Matrix-240/480TECO DIAGNOSTICSCDQ2023-07-21
10673486001242Teco Diagnostics Urea Nitrogen (BUN) Reagent SetTECO DIAGNOSTICSCDQ2023-07-21
10673486001259Teco Diagnostics Urea Nitrogen (BUN) Reagent SetTECO DIAGNOSTICSCDQ2023-07-21
00811727016058Pointe BUN ReagentHORIBA INSTRUMENTS INCORPORATEDCDQ2021-01-30
03610230007211Yumizen C1200 UreaHORIBA ABX SASCDQ2020-08-28
00811727015747Pointe BUN on BS480HORIBA INSTRUMENTS INCORPORATEDCDQ2020-05-28
07613336121603Urea/BunRoche Diagnostics GmbHCDQ2020-03-05
00380740161774ARCHITECTAbbott GmbHCDQ2020-01-25
00380740161781ARCHITECTAbbott GmbHCDQ2020-01-25
05055273216172UREARANDOX LABORATORIES LIMITEDCDQ2019-06-03
00386100001988BUN Reagent Kit MEDICA CORPORATIONCDQ2019-02-14
00380740121662AlinityAbbott GmbHCDQ2018-08-31
00380740121679AlinityAbbott GmbHCDQ2018-08-31
00852169008065ClearChem Diagnostics Inc. Blood Urea Nitrogen (BUN)CLEARCHEM DIAGNOSTICS INC.CDQ2018-04-30
00817274022672JAS DiagnosticsDREW SCIENTIFIC, INC.CDQ2018-04-26
00630414596471Atellica CH UN_cSiemens Healthcare Diagnostics Inc.CDQ2017-12-22
05060500091736Synermed®INFRARED LABORATORY SYSTEMS LLCCDQ2017-02-28
05060500091743Synermed®INFRARED LABORATORY SYSTEMS LLCCDQ2017-02-28
05060500091750Synermed®INFRARED LABORATORY SYSTEMS LLCCDQ2017-02-28
05060500091767Synermed®INFRARED LABORATORY SYSTEMS LLCCDQ2017-02-28
05060500091774Synermed®INFRARED LABORATORY SYSTEMS LLCCDQ2017-02-28
05060500091781Synermed®INFRARED LABORATORY SYSTEMS LLCCDQ2017-02-28
05060500091798Synermed®INFRARED LABORATORY SYSTEMS LLCCDQ2017-02-28