FDA.reportPublic FDA data

Syva® Emit® Calibrator B Level 2 (high)

Primary DI
00842768001802
Brand
Syva® Emit® Calibrator B Level 2 (high)
Company
Siemens Healthcare Diagnostics Inc.
Model
10445413
Catalog number
9A899UL
Device description
Syva® Emit® Calibrator B Level 2 (high)
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
DKBCALIBRATORS, DRUG MIXTURE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DKBCalibrators, Drug MixtureClinical Toxicology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K971600000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K971600000EMIT CALIBRATOR B LEVEL 1 (CUTOFF)/EMIT CALIBRATOR B LEVEL 2 (HIGH)Behring Diagnostics, Inc.1997-06-25DKB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00842768001802PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842768001802008427680018028427680018020842768001802

GMDN Terms#

Term, Definition table
TermDefinition
Amphetamine/methamphetamine group IVD, calibratorA material which is used to establish known points of reference for an assay intended to be used for the qualitative and/or quantitative detection of the amphetamine and/or methamphetamine group(s) in a clinical specimen.

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(800)227-8994XX@XX.XX
+1(800)227-8994CONTACT@SIEMENS-HEALTHINEERS.COM

Regulatory Flags#

DUNS number
005088112
Device count
1
Lot or batch
true
Expiration date on label
true

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00630414498942ADVIA® Chemistry ACET Acetaminophen Reagents1032738179891382016-09-24
00630414568768ADVIA® Chemistry BENZ_2 Benzodiazepine_2 Reagents10378760103787602016-09-24
00630414611075Atellica CH Crea311537215115372152026-05-08
00630414653259Atellica CH Crea311537567115375672026-05-08
00630414618456ADVIA CENTAUR ELF MCM SET11208709112087092023-03-15
00630414506005ADVIA® Chemistry HAPT Haptoglobin Reagents103141648310082016-09-24
00630414595795Atellica CH ECre_211097533110975332017-12-22
00842768015281Dimension Vista® Flex® reagent cartridge LIDO10445132K41132016-09-24
00630414291338ADVIA Centaur Cytokeratin Fragment 21-1 (CYFRA)11354590113545902026-04-16
00630414291345Atellica IM CYFRA 21-111354591113545912026-04-16
00630414292779Siemens Healthineers CYFRA 21-1 MCM11536187115361872026-04-16
00630414292786Atellica IM CYFRA 21-1 MCM11536188115361882026-04-16
00630414611693ADVIA Centaur Cytokeratin Fragment 21-1 Calibrator (CYFRA CAL)11553956115539562026-04-16
00630414622804Atellica IM CYFRA21-1 Calibrator11553957115539572026-04-16
00630414654041Atellica CH Ca11645759116457592026-04-08
00630414654102Atellica CH ALP_2c11645758116457582026-04-08

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00811727017574Pointe Multi-Analyte Set C Urine DAU Intermediate CalibratorHORIBA INSTRUMENTS INCORPORATEDDKB2020-09-25
00811727017581Pointe Multi-Analyte Set C Urine DAU High CalibratorHORIBA INSTRUMENTS INCORPORATEDDKB2020-09-25
00811727017611Pointe Multi-Analyte Set D Urine DAU Negative CalibratorHORIBA INSTRUMENTS INCORPORATEDDKB2020-09-25
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00811727017635Pointe Multi-Analyte Set D Urine DAU Cutoff CalibratorHORIBA INSTRUMENTS INCORPORATEDDKB2020-09-25
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00811727017710Pointe Multi-Analyte E DAU Intermediate CalibratorHORIBA INSTRUMENTS INCORPORATEDDKB2020-09-25
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