FDA.reportPublic FDA data

Atellica CH DLDL

Primary DI
00630414596181
Brand
Atellica CH DLDL
Company
Siemens Healthcare Diagnostics Inc.
Model
11097632
Catalog number
11097632
Device description
LDL Cholesterol Direct (D LDL) Atellica CH - RGT 1600T
Published
2020-09-24
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
MRRSYSTEM, TEST, LOW DENSITY, LIPOPROTEIN

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MRRSystem, Test, Low Density, LipoproteinClinical Chemistry1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K982529000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K982529000RANDOX DIRECT LDL CHOLESTEROLRandox Laboratories, Ltd.1998-09-11MRR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00630414596181PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00630414596181006304145961816304145961810630414596181

GMDN Terms#

Term, Definition table
TermDefinition
Low density lipoprotein (LDL) cholesterol IVD, kit, enzyme spectrophotometryA collection of reagents and other associated materials intended to be used for the quantitative measurement of low density lipoprotein (LDL) cholesterol lipid in a clinical specimen, using an enzyme spectrophotometry method.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Protect From Light
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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00630414596167Atellica CH ASO_211097634110976342020-09-24
00630414596259Atellica CH PreAlb11097617110976172020-09-24
00630414596440Atellica CH GGT11097597110975972020-09-24
00630414596174Atellica CH hsCRP11097633110976332017-12-21
00630414596198Atellica CH CRP_211097631110976312017-12-27
00630414597508Atellica CH hsCRP Calibrator11099412110994122017-12-22
00630414597515Atellica CH CRP_2 Calibrator11099430110994302017-12-22
00630414611075Atellica CH Crea311537215115372152026-05-08
00630414611297Atellica CH RCRP Cal11537245115372452024-02-02
00842768037726Dimension EXL LOCI Troponin I High Sensitive10471068104710682019-10-16
00630414596099Atellica CH Thc11097503110975032017-12-27
00630414510156ADVIA® Chemistry PAMY Pancreatic Amylase Reagents1031517814108202016-09-24
00630414595641Atellica CH PAmy11097622110976222017-12-21
00630414608273ADVIA Centaur Tumor Marker Quality Control (TM QC)11538186115381862026-05-29
00630414622859Atellica IM Tumor Marker Quality Control (TM QC)11538187115381872026-05-29
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
00630414653259Atellica CH Crea311537567115375672026-05-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06935740725705Blood Lipid AnalyzerUrit Medical Electronic Co., Ltd.MRR2026-06-03
06935740725712Blood Lipid AnalyzerUrit Medical Electronic Co., Ltd.MRR2026-06-03
06935740726986Blood Lipid Test StripUrit Medical Electronic Co., Ltd.MRR2024-07-12
10673486002010Teco Diagnostics Direct LDL Cholesterol Reagent SetTECO DIAGNOSTICSMRR2023-11-13
06971674860587BIOBASEBiobase Biodustry(Shandong)Co., Ltd.MRR2023-07-12
06971674860594BIOBASEBiobase Biodustry(Shandong)Co., Ltd.MRR2023-07-12
06971674860600BIOBASEBiobase Biodustry(Shandong)Co., Ltd.MRR2023-07-12
06971674860617BIOBASEBiobase Biodustry(Shandong)Co., Ltd.MRR2023-07-12
06971674860624BIOBASEBiobase Biodustry(Shandong)Co., Ltd.MRR2023-07-12
06971674860631BIOBASEBiobase Biodustry(Shandong)Co., Ltd.MRR2023-07-12
06971674860648BIOBASEBiobase Biodustry(Shandong)Co., Ltd.MRR2023-07-12
06971674860655BIOBASEBiobase Biodustry(Shandong)Co., Ltd.MRR2023-07-12
06971674860662BIOBASEBiobase Biodustry(Shandong)Co., Ltd.MRR2023-07-12
06971674860679BIOBASEBiobase Biodustry(Shandong)Co., Ltd.MRR2023-07-12
06971674860686BIOBASEBiobase Biodustry(Shandong)Co., Ltd.MRR2023-07-12
06971674860693BIOBASEBiobase Biodustry(Shandong)Co., Ltd.MRR2023-07-12
06971674860709BIOBASEBiobase Biodustry(Shandong)Co., Ltd.MRR2023-07-12
06971674860716BIOBASEBiobase Biodustry(Shandong)Co., Ltd.MRR2023-07-12
06971674860723BIOBASEBiobase Biodustry(Shandong)Co., Ltd.MRR2023-07-12
06971674860730BIOBASEBiobase Biodustry(Shandong)Co., Ltd.MRR2023-07-12
06971674860747BIOBASEBiobase Biodustry(Shandong)Co., Ltd.MRR2023-07-12
06971674860754BIOBASEBiobase Biodustry(Shandong)Co., Ltd.MRR2023-07-12
06971674860761BIOBASEBiobase Biodustry(Shandong)Co., Ltd.MRR2023-07-12
05055273213966DIRECT LDL-CHOLESTEROL (LDL)RANDOX LABORATORIES LIMITEDMRR2022-10-04
00817302024142CAROLINA LIQUID CHEMISTRIES CORP.® LDL CHOLESTEROL DIRECT REAGENT KIT AU-661CAROLINA LIQUID CHEMISTRIES CORPORATIONMRR2022-08-19
00817302024227CAROLINA LIQUID CHEMISTRIES CORP.® LDL CHOLESTEROL DIRECT REAGENT KIT BL661CAROLINA LIQUID CHEMISTRIES CORPORATIONMRR2022-08-19
00817302024487CAROLINA LIQUID CHEMISTRIES CORP.® LDL CHOLESTEROL DIRECT REAGENT KIT DT661CAROLINA LIQUID CHEMISTRIES CORPORATIONMRR2022-08-19
00817302024623CAROLINA LIQUID CHEMISTRIES CORP.® LDL CHOLESTEROL DIRECT REAGENT KIT ST661CAROLINA LIQUID CHEMISTRIES CORPORATIONMRR2022-08-19
00630414611037Atellica CH LDLCSiemens Healthcare Diagnostics Inc.MRR2022-07-08
00630414305073Atellica CH LDLCSiemens Healthcare Diagnostics Inc.MRR2022-07-08