FDA.reportPublic FDA data

Elecsys Cortisol Test System

Primary DI
04015630938933
Brand
Elecsys Cortisol Test System
Company
Roche Diagnostics GmbH
Model
11875116160
Catalog number
11875116160
Published
2016-09-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
NHGENZYME IMMUNOASSAY, CORTISOL, SALIVARY

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NHGEnzyme Immunoassay, Cortisol, SalivaryClinical Chemistry2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04015630938933PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04015630938933040156309389334015630938933

GMDN Terms#

Term, Definition table
TermDefinition
Total cortisol IVD, kit, chemiluminescent immunoassayA collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of total cortisol in a clinical specimen, using a chemiluminescent immunoassay method.

Storage And Handling#

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

Regulatory Flags#

DUNS number
315028860
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07613336234457PreciControl Syphilis09465022190094650221902026-05-15
04015630913893AMYP Amylase EPS Pancreatic20766623322207666233222016-09-20
04015630910991alpha-Amylase liquid acc. to IFCC11876473316118764733162016-09-20
04015630911004Pancreatic alpha-amylase liquid11876562316118765623162016-09-20
04015630926848alpha-Amylase EPS Pancreatic540177119054017711902016-09-20
07613336121016a-Amylase EPS Pancreatic08056820190080568201902020-03-05
07613336171509Elecsys Calcitonin09005676190090056761902026-06-01
07613336171516CalSet Calcitonin09005684190090056841902026-06-01
07613336188064Elecsys Calcitonin09005668160090056681602026-06-01
07613336217641Elecsys Anti-TSHR09744819190097448191902026-06-01
07613336218341Elecsys CA 19-909755608190097556081902026-06-01
07613336218389Elecsys Estradiol III09755659190097556591902026-06-01
07613336235546PreciControl HIV Gen II09465006160094650061602026-05-22
07613336231432Tina-quant Antistreptolysin-O II09537368190095373681902026-05-08
07613336231449Tina-quant Antistreptolysin-O II09537341190095373411902026-05-08
07613336154342Elecsys Anti-HBc IgM11820567160118205671602017-09-29
07613336217832Elecsys Testosterone II09745963190097459631902026-04-21
07613336153932Elecsys Anti-HBc IgM07026811160070268111602018-03-19
00875197004748cobas® HBV/HCV/HIV-1 Control Kit1.0069988871902015-12-04
07613336203606Elecsys Anti-HBc II09014918160090149181602022-04-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00850039602078Pantex P631SCPantexNHG2022-05-23
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00850039602108Pantex P631SCPantexNHG2022-05-23
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00850039602153Pantex UniversalPantexNHG2022-05-23
00850039602009Pantex P631SCPantexNHG2022-05-23
10850039602020Pantex P631SCPantexNHG2022-05-23
10850039602037Pantex P631SCPantexNHG2022-05-23
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10850039602105Pantex P631SCPantexNHG2022-05-23
10850039602112Pantex P631SCPantexNHG2022-05-23
10850039602129Pantex P631SCPantexNHG2022-05-23
10850039602136Pantex P631SCPantexNHG2022-05-23
10850039602143Pantex P631SCPantexNHG2022-05-23