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Elecsys IgE CalSet

Primary DI
04015630911134
Brand
Elecsys IgE CalSet
Company
Roche Diagnostics GmbH
Model
11930427122
Catalog number
11930427122
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
JHRRADIOIMMUNOASSAY, IMMUNOGLOBULINS (D, E)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JHRRadioimmunoassay, Immunoglobulins (D, E)Immunology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K984326000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K984326000ELECYS IGE ASSAYBoehringer Mannheim Corp.1999-02-08JHR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04015630911134PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04015630911134040156309111344015630911134

GMDN Terms#

Term, Definition table
TermDefinition
Plasma protein IVD, calibratorA material which is used to establish known points of reference for an assay intended to be used for the quantitative measurement of plasma proteins in a clinical specimen.

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
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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
07613336203613Elecsys Anti-HBc II09014926160090149261602022-04-11
04015630938858Elecsys AntiHAV IgM11820591160118205911602016-09-20
04015630939855Elecsys Anti-HAV IgM07026773190070267731902017-09-07
07613336224397cobas ISE neo 1800 analytical unit09687416001096874160012026-04-03
20875197004766cobas&#x00AE MPX (96 tests)06998909190069989091902017-02-14
00875197004779cobas&#x00AE MPX (480 tests)06998917190069989171902017-02-14
07613336146996cobas® Microbial Inactivation Solution08185476001081854760012026-03-26
07613336200544cobas c 703 analytical unit09502971001095029710012026-03-20
07613336220191cobas pro SBL c 70309796754001097967540012026-03-20
07613336222331ISE Internal Standard Gen.2 conc.09137742190091377421902026-03-20
04015630926091Testosterone II CalSet II05202230190052022301902026-02-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04015630940226Elecsys IgE IIRoche Diagnostics GmbHJHR2017-04-14
00630414953458IMMULITE® Systems TIE CONTROL Total IgESIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDJHR2016-09-24
00630414954356IMMULITE®/IMMULITE® 1000 Systems TIE Total IgE Sample DiluentSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDJHR2016-09-24
00630414966083IMMULITE® 2000 Systems TIE Total IgESIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDJHR2016-09-24
00630414966090IMMULITE® 2000 Systems TIE Total IgESIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDJHR2016-09-24
00630414966137IMMULITE®/IMMULITE® 1000 Systems TIE Total IgESIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDJHR2016-09-24
04015630922369Elecsys IgE II ImmunoassayRoche Diagnostics GmbHJHR2016-09-20