FDA.reportPublic FDA data

Atellica IM PCT QC

Primary DI
00630414599700
Brand
Atellica IM PCT QC
Company
Siemens Healthcare Diagnostics Inc.
Model
10995652
Catalog number
10995652
Device description
Procalcitonin (PCT) QC Kit Atellica IM - CLT 2 x 2 x 5.0mL
Published
2018-02-06
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
NTMAntigen, inflammatory response marker, sepsis

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NTMAntigen, Inflammatory Response Marker, SepsisMicrobiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00630414599700PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00630414599700006304145997006304145997000630414599700

GMDN Terms#

Term, Definition table
TermDefinition
Procalcitonin (PCT) IVD, controlA material which is used to verify the performance of an assay intended to be used for the quantitative measurement of procalcitonin (PCT) in a clinical specimen.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store Upright, Protect from Light, Do not freeze, Resuspend.
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
Premarket exempt
true
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
00816870023441PCT AccuLite CLIA Test System - 96 WellsMONOBIND, INC.NTM2024-09-13
00816870023458PCT AccuLite CLIA Test System - 192 WellsMONOBIND, INC.NTM2024-09-13
00816870023465PCT AccuBind ELISA Test System - 96 WellsMONOBIND, INC.NTM2024-09-13
00816870023472PCT AccuBind ELISA Test System - 192 WellsMONOBIND, INC.NTM2024-09-13
04987270234938Lumipulse G BRAHMS PCT Calibrator SetFUJIREBIO INC.NTM2018-04-02
04987270234945Lumipulse BRAHMS PCT ControlsFUJIREBIO INC.NTM2018-04-02
04987270234167Lumipulse BRAHMS PCT ControlsFUJIREBIO INC.NTM2018-04-02
04987270235058Lumipulse G BRAHMS PCT Immunoreaction CartridgesFUJIREBIO INC.NTM2018-04-02
00630414599694Atellica IM PCTSiemens Healthcare Diagnostics Inc.NTM2018-02-06
00895160002427Fluoro-CheckTM PCTNANO-DITECH CORPORATIONNTM2016-10-05
03573026223601VIDAS® B·R·A·H·M·S PCT ™BIOMERIEUX SANTM2016-09-23
00895160002038Nano-CheckTM PCTNANO-DITECH CORPORATIONNTM2016-09-14
00895160002441Nano-CheckTM PCT plusNANO-DITECH CORPORATIONNTM2016-09-12
04260157630543B.R.A.H.M.S PCT LIAB.R.A.H.M.S GmbHNTM2016-08-17
04260157633711B.R.A.H.M.S Basiskit LIAB.R.A.H.M.S GmbHNTM2016-08-17
04260157638259B.R.A.H.M.S PCT sensitive KRYPTOR B.R.A.H.M.S GmbHNTM2016-08-17