FDA.reportPublic FDA data

Lumipulse BRAHMS PCT Controls

Primary DI
04987270234167
Brand
Lumipulse BRAHMS PCT Controls
Company
FUJIREBIO INC.
Model
234167
Published
2018-04-02
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K172713000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K172713000Lumipulse G B•R•A•H•M•S PCT Immunoreaction Cartridges, Lumipulse G B•R•A•H•M•S PCT Calibrators setFujirebio Diagnostics,Inc.2017-12-10PRI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04987270234167PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04987270234167049872702341674987270234167

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature2 Degrees Celsius10 Degrees Celsius
Special Storage Condition, Specify00right side up with care, no vibration
Storage Environment Temperature2 Degrees Celsius10 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
610-240-3800customersupport@fdi.com

Regulatory Flags#

DUNS number
710873907
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
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
04987270235058Lumipulse G BRAHMS PCT Immunoreaction Cartridges2350582018-04-02
04987270235584Lumipulse Infectious Diseases Controls2355842025-07-31
04987270230466Lumipulse G Dilution Cartridges2304662019-12-27
04987270234440Soda Lime for LUMIPULSE System2344402020-01-10
04987270235447Lumipulse G B-Amyloid 1-42-N Plasma2354472025-01-06
04987270235454Lumipulse G B-Amyloid 1-42-N Plasma Calibrator2354542025-01-06
04987270235485Lumipulse G B-Amyloid Controls (Plasma)-N2354852025-01-06
04987270226964Beckman Coulter PK TP System226964PH30002016-09-16
04987270234938Lumipulse G BRAHMS PCT Calibrator Set2349382018-04-02
04987270234945Lumipulse BRAHMS PCT Controls2349452018-04-02
04987270234884Lumipulse G B-Amyloid 1-42 Calibrator Set2348842022-10-31
04987270234891Lumipulse G B-Amyloid 1-40 Calibrator Set2348912022-10-31
04987270234907Lumipulse B-Amyloid Controls2349072022-10-31
04987270231432Lumipulse G B-Amyloid 1-42 Immunoreaction Cartridges2314322022-11-10
04987270231753Lumipulse G B-Amyloid 1-40 Immunoreaction Cartridges2317532022-11-10
04987270231869Lumipulse G SARS-CoV-2 Ag Calibrator Set2318692023-02-01
04987270231876Lumipulse SARS-CoV-2 Ag Controls2318762023-02-01
04987270260340Lumipulse G SARS-CoV-2 Ag Immunoreaction Cartridges2603402023-02-01
04987270234259LUMIPULSE G12002342592019-12-27
04987270230190Lumipulse G whole PTH Immunoreaction Cartridges2301902019-12-18

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
04987270235058Lumipulse G BRAHMS PCT Immunoreaction CartridgesFUJIREBIO INC.NTM2018-04-02
00630414599694Atellica IM PCTSiemens Healthcare Diagnostics Inc.NTM2018-02-06
00630414599700Atellica IM PCT QCSiemens 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