FDA.reportPublic FDA data

Atellica CH uALB_2

Primary DI
00630414596310
Brand
Atellica CH uALB_2
Company
Siemens Healthcare Diagnostics Inc.
Model
11097610
Catalog number
11097610
Device description
Microalbumin (µALB_2) Atellica CH - RGT 840T
Published
2020-09-24
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
JIRINDICATOR METHOD, PROTEIN OR ALBUMIN (URINARY, NON-QUANT.)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JIRIndicator Method, Protein Or Albumin (Urinary, Non-Quant.)Clinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00630414596310PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00630414596310006304145963106304145963100630414596310

GMDN Terms#

Term, Definition table
TermDefinition
Microalbumin IVD, kit, nephelometry/turbidimetryA collection of reagents and other associated materials intended to be used for the quantitative measurement of microalbumin in a clinical specimen, using a nephelometry/turbidimetry method.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
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
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
00630414287201Atellica HEMA Calibrator11374312113743122026-02-06
00630414289694Atellica HEMA 580 Analyzer (SMS ready)11315457113154572026-02-06
00630414289700Atellica HEMA Slidemaker Stainer (SMS)11315459113154592026-02-06
00630414289953Atellica HEMA Diluent11374303113743032026-02-06
00630414289960Atellica HEMA Diluent11374304113743042026-02-06
00630414312460Atellica HEMA Cleaner11374306113743062026-02-06
00630414312477Atellica HEMA HGB11374307113743072026-02-06
00630414290003Atellica HEMA Baso11374308113743082026-02-06
00630414312484Atellica HEMA RET/PLTO11374309113743092026-02-06
00630414312491Atellica HEMA Diff11374310113743102026-02-06
00630414312507Atellica HEMA Decon11374311113743112026-02-06
00630414323640Atellica HEMA Control (L)11374313113743132026-02-06
00630414323657Atellica HEMA Control (N)11374314113743142026-02-06
00630414323534Atellica HEMA Control (H)11374315113743152026-02-06
00630414323541Atellica HEMA Retic Control (L)11374316113743162026-02-06
00630414323558Atellica HEMA Retic Control (N)11374317113743172026-02-06
00630414323565Atellica HEMA Retic Control (H)11374318113743182026-02-06
00630414323572Atellica HEMA Control BF (N)11374319113743192026-02-06
00630414323589Atellica HEMA Control BF (H)11374320113743202026-02-06
00630414323596Atellica HEMA SMS W-G Stain11559862115598622026-02-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
40884389181943MEDLINEMEDLINE INDUSTRIES, INC.JIR2025-04-29
00850054026781QMedix™Diagnostic Automation, Inc.JIR2024-10-29
10673486000528Teco Diagnostics TC-Thunderbolt Automated Urine Analyzer SystemTECO DIAGNOSTICSJIR2024-06-06
10673486000498Teco Diagnostics Uritek TC-720+ Urine Chemistry Test SystemTECO DIAGNOSTICSJIR2024-06-05
00198168683255Micro-AlbuminORGENTEC Diagnostika GmbHJIR2023-12-14
00850049545921InstaTestDiagnostic Automation, Inc.JIR2023-06-14
00657498002094Uri-Trak 120 M Urine AnalyzerSTANBIO LABORATORY, L.P.JIR2023-06-08
05055273206814TOTAL PROTEIN (UP)RANDOX LABORATORIES LIMITEDJIR2022-10-05
08806141302025One+Step ProteinDFI CO.,LTDJIR2022-10-03
80888277677790MedlineMEDLINE INDUSTRIES, INC.JIR2022-08-04
10673486000092TECO DIAGNOSTICSTECO DIAGNOSTICSJIR2021-05-07
00630414517643ADVIA® Chemistry µALB Microalbumin ReagentsSiemens Healthcare Diagnostics Inc.JIR2020-09-24
50885380175563CARDINAL HEALTHCardinal Health 200, LLCJIR2020-06-30
08806141302087CYBOW P DFI CO.,LTDJIR2020-06-29
08806141302094CYBOW PDFI CO.,LTDJIR2020-06-29
10673486000672TECO DIAGNOSTICSTECO DIAGNOSTICSJIR2020-03-09
07613336120965Tina-quant Albumin Gen.2Roche Diagnostics GmbHJIR2020-03-05
04048474038811Micro-Albumin ELISADRG Instruments Gesellschaft mit beschränkter HaftungJIR2019-06-05
00404847438819Micro-Albumin ELISADRG Instruments Gesellschaft mit beschränkter HaftungJIR2019-06-05
05055273209587TOTAL PROTEIN (UP)RANDOX LABORATORIES LIMITEDJIR2019-06-03
00840239038814Micro-Albumin ELISADRG International IncJIR2019-03-20
00722066004388Rapid ResponseBTNX IncJIR2019-02-06
10722066004392Rapid ResponseBTNX IncJIR2019-02-06
20722355002921Detector UA 10SGIMMUNOSTICS COMPANY, INCJIR2018-11-20
10673486000566TECO DIAGNOSTICSTECO DIAGNOSTICSJIR2018-02-12
00630414027364DCA® Systems Microalbumin/Creatinine Capillary holders and plungersSiemens Healthcare Diagnostics Inc.JIR2017-03-01
10673486000351TECO DIAGNOSTICSTECO DIAGNOSTICSJIR2017-01-05
10673486000375TECO DIAGNOSTICSTECO DIAGNOSTICSJIR2017-01-05
00722066000366Rapid ResponseBTNX IncJIR2016-10-17
00722066003640Rapid ResponseBTNX IncJIR2016-10-17