DM EXL LOCI BRAHMS PCT

Primary DI
00630414298214
Brand
DM EXL LOCI BRAHMS PCT
Company
Siemens Healthcare Diagnostics Inc.
Model
11354447
Catalog number
RF648
Device description
Procalcitonin (PCT) DM EXL LOCI BRAHMS - RGT
Published
2022-11-15
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
PMTDevice to detect and measure procalcitonin (PCT) in human clinical specimens

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PMTDevice To Detect And Measure Procalcitonin (Pct) In Human Clinical SpecimensMicrobiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K220262000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K220262000Dimension EXL LOCI BRAHMS Procalcitonin (PCT)Siemens Healthcare Diagnostics, Inc.2022-08-26PRI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00630414238692PrimaryGS10
00630414298214Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00630414238692006304142386926304142386920630414238692
00630414298214006304142982146304142982140630414298214

GMDN Terms#

Term, Definition table
TermDefinition
Procalcitonin (PCT) IVD, reagentA substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the quantitative measurement of procalcitonin (PCT) in a clinical specimen.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature2 Degrees Celsius8 Degrees Celsius
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)441-9250CONTACT@SIEMENS-HEALTHINEERS.COM

Regulatory Flags#

DUNS number
005088112
Device count
4
DM exempt
false
Premarket exempt
false
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

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Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00630414238692DM EXL LOCI BRAHMS PCTSiemens Healthcare Diagnostics Inc.PMT2022-11-15
10758750032938VITROSORTHO CLINICAL DIAGNOSTICSPMT2020-05-16
10758750032945VITROSORTHO CLINICAL DIAGNOSTICSPMT2020-05-16
10758750033287VITROSORTHO CLINICAL DIAGNOSTICSPMT2020-05-16
10758750033294VITROSORTHO CLINICAL DIAGNOSTICSPMT2020-05-16
00380740153953AlinityAbbott Ireland DiagnosticsPMT2019-01-04
00630414246550Atellica IM BRAHMS PCTSiemens Healthcare Diagnostics Inc.PMT2018-10-05
04987270234945Lumipulse BRAHMS PCT ControlsFUJIREBIO INC.PMT2018-04-02
04987270235058Lumipulse G BRAHMS PCT Immunoreaction CartridgesFUJIREBIO INC.PMT2018-04-02
00380740138905ARCHITECTAbbott GmbHPMT2017-08-16
00380740138912ARCHITECTAbbott GmbHPMT2017-08-16
00380740139032ARCHITECTAbbott GmbHPMT2017-08-16
00380740139049ARCHITECTAbbott GmbHPMT2017-08-16
04260157632875B.R.A.H.M.S PCT sensitive KRYPTOR CALB.R.A.H.M.S GmbHPMT2017-08-15
04015630940073Elecsys BRAHMS PCTRoche Diagnostics GmbHPMT2017-04-21
03573026223601VIDAS® B·R·A·H·M·S PCT ™BIOMERIEUX SAPMT2016-09-23
04015630939114Elecsys BRAHMS PCTRoche Diagnostics GmbHPMT2016-09-20
04260157630949B.R.A.H.M.S KRYPTOR compact PLUS B.R.A.H.M.S GmbHPMT2016-08-17
04260157632882B.R.A.H.M.S PCT sensitive KRYPTOR QC B.R.A.H.M.S GmbHPMT2016-08-17
04260157633216B.R.A.H.M.S KRYPTOR compact SOLUTION 1 B.R.A.H.M.S GmbHPMT2016-08-17
04260157633223B.R.A.H.M.S KRYPTOR compact SOLUTION 2 B.R.A.H.M.S GmbHPMT2016-08-17
04260157633230B.R.A.H.M.S KRYPTOR compact SOLUTION 3 B.R.A.H.M.S GmbHPMT2016-08-17
04260157633247B.R.A.H.M.S KRYPTOR compact SOLUTION 4B.R.A.H.M.S GmbHPMT2016-08-17
04260157638259B.R.A.H.M.S PCT sensitive KRYPTOR B.R.A.H.M.S GmbHPMT2016-08-17
04260157638976B.R.A.H.M.S KRYPTOR compact REACTB.R.A.H.M.S GmbHPMT2016-08-17
04260157638983B.R.A.H.M.S KRYPTOR compact DILCUPB.R.A.H.M.S GmbHPMT2016-08-17
04260157638990B.R.A.H.M.S KRYPTOR BUFFERB.R.A.H.M.S GmbHPMT2016-08-17