FDA.reportPublic FDA data

IMMULITE® Systems TIE CONTROL Total IgE

Primary DI
00630414953458
Brand
IMMULITE® Systems TIE CONTROL Total IgE
Company
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
Model
10385349
Catalog number
IECM
Device description
IgE total - IMMULITE - CTL - 2x2mL
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

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
K901859000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K901859000COAT-A-COUNT TOTAL IGE IRMA, CATALOG #IKIE1, IKIE2Diagnostic Products Corp.1990-05-03JHR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00630414953458PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00630414953458006304149534586304149534580630414953458

GMDN Terms#

Term, Definition table
TermDefinition
Total immunoglobulin E (IgE total) IVD, controlA material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of total immunoglobulin E (IgE total) 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(877)229-3711XX@XX.XX
+1(877)229-3711CONTACT@SIEMENS-HEALTHINEERS.COM

Regulatory Flags#

DUNS number
296822794
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00630414965017IMMULITE®/IMMULITE® 1000 Systems SUBS10385394LSUBX2020-09-24
00630414961125IMMULITE® 2000 Systems CEA10380995L2KCE62016-09-24
00630414964980IMMULITE®/IMMULITE® 1000 Systems RPT Turbo Intact PTH10381430LSKPTZ2016-09-24
00630414970110IMMULITE®/IMMULITE® 1000 Systems T4 Total T410381635LKT452016-09-24
00630414972923IMMULITE®2000 Systems Diluent Tube Caps10385211L2ZC2020-09-24
00630414965734IMMULITE® 2000 Systems Allergen Tube Caps10282837L2ATC2020-09-24
00630414965741IMMULITE® 2000 Systems Allergen Tubes10282849L2ATS22020-09-24
00630414973159IMMULITE® 2000 Systems Diluent Tubes10385210L2ZT2020-09-24
00630414974064IMMULITE® 2000 Systems Microsampling Tube Caps10385205LSMC2020-09-24
00630414954547IMMULITE® 2000 Systems Reaction Tubes10385206LRXT2016-09-24
00630414973937IMMULITE® 2000 Systems Microsampling Tubes10385207LMST2016-09-24
00630414982403IMMULITE® 2000 XPi Sample Nesting Cups103741789052882016-09-24
00630414982410IMMULITE® 2000 Xpi Sample Nesting Cups103741799052892016-09-24
00630414961538IMMULITE® 2000 Systems IGF-110381448L2KGF22020-09-24
00630414245317Atellica IM Anti-Thyroglobulin II (aTgII)11201759112017592026-02-04
00630414245324Atellica IM Anti-Thyroglobulin II (aTgII)11201761112017612026-02-04
00630414245331Atellica IM aTgII Quality Control (aTgII QC)11201752112017522026-02-04
00630414245348Atellica IM aTgII Master Curve Material (aTgII MCM)11201751112017512026-02-04
00630414245355ADVIA Centaur Anti-Thyroglobulin II (aTgII)11201758112017582026-02-04
00630414245362ADVIA Centaur Anti-Thyroglobulin II (aTgII)11201760112017602026-02-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04015630940226Elecsys IgE IIRoche Diagnostics GmbHJHR2017-04-14
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
04015630911134Elecsys IgE CalSetRoche Diagnostics GmbHJHR2016-09-20
04015630922369Elecsys IgE II ImmunoassayRoche Diagnostics GmbHJHR2016-09-20