FDA.reportPublic FDA data

Atellica IM Androstenedione MCM

Primary DI
00630414285559
Brand
Atellica IM Androstenedione MCM
Company
Siemens Healthcare Diagnostics Inc.
Model
11200557
Catalog number
11200557
Device description
Androstenedione (Andro) Atellica IM - Master Curve Material 5x1x1.0mL
Published
2019-12-04
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
JJXSingle (specified) analyte controls (assayed and unassayed)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JJXSingle (Specified) Analyte Controls (Assayed And Unassayed)Clinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00630414285559PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00630414285559006304142855596304142855590630414285559

GMDN Terms#

Term, Definition table
TermDefinition
Androstenedione IVD, controlA material which is used to verify the performance of an assay intended to be used for the quantitative measurement of androstenedione in a clinical specimen.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store below -20 deg C, Store Upright, Protect from Light & Keep Frozen Until Use

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
064608573
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00630414287201Atellica HEMA Calibrator11374312113743122026-02-06
00630414289694Atellica HEMA 580 Analyzer (SMS ready)11315457113154572026-02-06
00630414289700Atellica HEMA Slidemaker Stainer (SMS)11315459113154592026-02-06
00630414289953Atellica HEMA Diluent11374303113743032026-02-06
00630414289960Atellica HEMA Diluent11374304113743042026-02-06
00630414312460Atellica HEMA Cleaner11374306113743062026-02-06
00630414312477Atellica HEMA HGB11374307113743072026-02-06
00630414290003Atellica HEMA Baso11374308113743082026-02-06
00630414312484Atellica HEMA RET/PLTO11374309113743092026-02-06
00630414312491Atellica HEMA Diff11374310113743102026-02-06
00630414312507Atellica HEMA Decon11374311113743112026-02-06
00630414323640Atellica HEMA Control (L)11374313113743132026-02-06
00630414323657Atellica HEMA Control (N)11374314113743142026-02-06
00630414323534Atellica HEMA Control (H)11374315113743152026-02-06
00630414323541Atellica HEMA Retic Control (L)11374316113743162026-02-06
00630414323558Atellica HEMA Retic Control (N)11374317113743172026-02-06
00630414323565Atellica HEMA Retic Control (H)11374318113743182026-02-06
00630414323572Atellica HEMA Control BF (N)11374319113743192026-02-06
00630414323589Atellica HEMA Control BF (H)11374320113743202026-02-06
00630414323596Atellica HEMA SMS W-G Stain11559862115598622026-02-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860003164594RosieSouthern Life Systems, Inc.JJX2026-03-02
00810079240593Teladoc Health, Inc.Teladoc Health, Inc.JJX2026-02-17
00630414245331Atellica IM aTgII Quality Control (aTgII QC)SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDJJX2026-02-04
00630414245348Atellica IM aTgII Master Curve Material (aTgII MCM)SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDJJX2026-02-04
00630414245379ADVIA Centaur aTgII Quality Control (aTgII QC)SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDJJX2026-02-04
00630414245386ADVIA Centaur aTgII Master Curve Material (aTgII MCM)SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDJJX2026-02-04
07613336224281PreciControl Rubella IgGRoche Diagnostics GmbHJJX2026-01-28
00630414608778Atellica IM aTPOII MCMSiemens Healthcare Diagnostics Inc.JJX2026-01-26
00630414608891Atellica IM aTPOII QCSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDJJX2026-01-26
00817089022478DiazymeDIAZYME LABORATORIES, INC.JJX2026-01-21
00817089023239DiazymeDIAZYME LABORATORIES, INC.JJX2026-01-21
MHC1101665152EasyTouchMHC MEDICAL PRODUCTS, LLCJJX2026-01-07
00850011135846VALIDATELgc Clinical Diagnostics, Inc.JJX2026-01-06
04560189283923Hemoglobin A1c Control SetTOSOH CORPORATIONJJX2026-01-05
00380740189839AlinityAbbott GmbHJJX2026-01-01
00380740189853ARCHITECTAbbott GmbHJJX2026-01-01
10758750032891VITROSORTHO CLINICAL DIAGNOSTICSJJX2025-12-30
00380740168759AlinityAbbott Ireland DiagnosticsJJX2025-12-11
40612479280517McKessonMCKESSON MEDICAL-SURGICAL INC.JJX2025-12-01
30840330706545TRUE METRIXTRIVIDIA HEALTH, INC.JJX2025-11-25
00630414608587ADVIA Centaur aTPOII QCSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDJJX2025-11-21
00630414608822ADVIA Centaur aTPOII MCMSiemens Healthcare Diagnostics Inc.JJX2025-11-21
07649996894090IVD CAPSULE Control PSPAbionic SAJJX2025-09-29
07649996894106abioSCOPE ControlAbionic SAJJX2025-09-29
00015482510060Assure® Control - Control Solution Level 2 & Level 3ARKRAY USA, INC.JJX2025-09-26
00810079240142LivongoLIVONGO HEALTH, INCJJX2025-09-25
00810079240463Teladoc Health, Inc.Teladoc Health, Inc.JJX2025-09-25
00810079240470Teladoc Health, Inc.Teladoc Health, Inc.JJX2025-09-25
00630414238401Atellica IM Thyroglobulin (Tg)SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDJJX2025-09-22
05711435000170ProNephro AKI™ (NGAL) Control KitBioporto Diagnostics A/SJJX2025-08-28