FDA.reportPublic FDA data

Immunoglobulin M

Primary DI
04015630913725
Brand
Immunoglobulin M
Company
Roche Diagnostics GmbH
Model
20737771322
Catalog number
20737771322
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
CFNMETHOD, NEPHELOMETRIC, IMMUNOGLOBULINS (G, A, M)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CFNMethod, Nephelometric, Immunoglobulins (G, A, M)Immunology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K982382000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K982382000COBAS INTEGRA REAGENT CASSETTESRoche Diagnostic Systems, Inc.1998-09-28CFN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04015630913725PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04015630913725040156309137254015630913725

GMDN Terms#

Term, Definition table
TermDefinition
Total immunoglobulin M (IgM total) IVD, kit, nephelometry/turbidimetryA collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of total immunoglobulin M (IgM total) in a clinical specimen, using a nephelometry/turbidimetry 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
05051700021036Optilite® IgG3 Kit (x10)THE BINDING SITE GROUP LIMITEDCFN2023-09-27
05051700021043Optilite® IgG4 Kit (x10)THE BINDING SITE GROUP LIMITEDCFN2023-09-27
05051700020916Optilite® IgG Kit (x10)THE BINDING SITE GROUP LIMITEDCFN2022-11-21
05051700020923Optilite® IgG1 Kit (x10)THE BINDING SITE GROUP LIMITEDCFN2022-11-21
05051700020930Optilite® IgG2 Kit (x10)THE BINDING SITE GROUP LIMITEDCFN2022-11-21
00630414285023N Latex IgMSiemens Healthcare Diagnostics Products GmbHCFN2020-05-29
05051700020183Optilite IgM CSF KitTHE BINDING SITE GROUP LIMITEDCFN2020-01-31
05051700020190Optilite IgA CSF KitTHE BINDING SITE GROUP LIMITEDCFN2019-06-21
00630414596266Atellica CH IgG_2Siemens Healthcare Diagnostics Inc.CFN2017-12-27
00630414595627Atellica CH IgM_2Siemens Healthcare Diagnostics Inc.CFN2017-12-21
00630414595610Atellica CH IgA_2Siemens Healthcare Diagnostics Inc.CFN2017-12-19
05051700019835Optilite IgG CSF KitTHE BINDING SITE GROUP LIMITEDCFN2017-05-26
15099590011574AUBeckman Coulter, Inc.CFN2016-09-24
15099590011581AUBeckman Coulter, Inc.CFN2016-09-24
15099590011598AUBeckman Coulter, Inc.CFN2016-09-24
05051700006033Human IgG Subclass Liquid Reagent Kit for use on the Siemens BN™II - Bulk KitTHE BINDING SITE GROUP LIMITEDCFN2016-09-24
05051700006088Human IgG Subclass Liquid Reagent Kit for use on the Siemens BN™IITHE BINDING SITE GROUP LIMITEDCFN2016-09-24
05051700006095Human IgA Subclass Liquid Latex Reagent Kit for use on the Siemens BN™II THE BINDING SITE GROUP LIMITEDCFN2016-09-24
05051700006101Human IgG3 Subclass Liquid Reagent Kit for use on the Siemens BN™II - Bulk KitTHE BINDING SITE GROUP LIMITEDCFN2016-09-24
05051700006118Olympus IgG3 KitTHE BINDING SITE GROUP LIMITEDCFN2016-09-24
05051700006132Human IgG3 Subclass Liquid Reagent Kit for use on Hitachi 911/912/917, Modular PTHE BINDING SITE GROUP LIMITEDCFN2016-09-24
05051700006149Beckman Immage IgG3 Latex KitTHE BINDING SITE GROUP LIMITEDCFN2016-09-24
05051700006163Human IgG3 Subclass Liquid Reagent Kit for use on the Siemens BN™IITHE BINDING SITE GROUP LIMITEDCFN2016-09-24
05051700006170Human IgG4 Subclass Liquid Reagent Kit for use on the Siemens BN™II) THE BINDING SITE GROUP LIMITEDCFN2016-09-24
05051700006187Human IgG4 Subclass Liquid Reagent Kit for use on the Beckman Coulter AU® seriesTHE BINDING SITE GROUP LIMITEDCFN2016-09-24
05051700006224Human IgG4 Subclass Liquid Reagent Kit for use on the Beckman IMMAGE®/IMMAGE®800THE BINDING SITE GROUP LIMITEDCFN2016-09-24
05051700006248Human IgG4 Subclass Liquid Reagent Kit for use on the Siemens BN™IITHE BINDING SITE GROUP LIMITEDCFN2016-09-24
05051700006538Human IgA2 Subclass Liquid Latex Reagent Kit for use on the Siemens BN™IITHE BINDING SITE GROUP LIMITEDCFN2016-09-24
05051700007535Human IgG Subclass Liquid Reagent Kit for use on the Siemens BN™II Bulk KitTHE BINDING SITE GROUP LIMITEDCFN2016-09-24
05051700007559Human IgG2 Subclass Liquid Reagent Kit for use on the Siemens BN™II - Bulk KitTHE BINDING SITE GROUP LIMITEDCFN2016-09-24