FDA.reportPublic FDA data

DM EXL LOCI BRAHMS PCT Cal Kit

Primary DI
00630414238708
Brand
DM EXL LOCI BRAHMS PCT Cal Kit
Company
Siemens Healthcare Diagnostics Inc.
Model
11354448
Catalog number
RC648
Device description
Procalcitonin (PCT) DM EXL LOCI BRAHMS - Cal Kit
Published
2022-11-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
JITCalibrator, secondary

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JITCalibrator, SecondaryClinical Chemistry2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00630414238708PrimaryGS10
00630414295039Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00630414238708006304142387086304142387080630414238708
00630414295039006304142950396304142950390630414295039

GMDN Terms#

Term, Definition table
TermDefinition
Procalcitonin (PCT) IVD, calibratorA material which is used to establish known points of reference for 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
Storage Environment Temperature-25 Degrees Celsius-15 Degrees Celsius

Contacts#

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

Regulatory Flags#

DUNS number
005088112
Device count
2
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

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00630414602875VERSANT HCV 2.0 LiPA10492004104920042017-09-15
00630414602882VERSANT HCV 2.0 LiPA10492005104920052017-09-15
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00630414508368ADVIA® Chemistry ALT(GPT) Reagents10309500103095002020-09-24
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00630414517445ADVIA® Chemistry Lactate Dehydrogenase P-L (LDPL) Reagents10341129103411292016-09-24
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Primary DI, Brand, Company table
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