FDA.reportPublic FDA data

Alinity

Primary DI
00380740136116
Brand
Alinity
Company
Abbott GmbH & Co. KG
Model
07P6810
Catalog number
07P6810
Device description
Alinity i 2nd Generation Testosterone Controls
Published
2018-07-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
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
00380740136116PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00380740136116003807401361163807401361160380740136116

GMDN Terms#

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

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Humidity0 Percent (%) Relative Humidity0 Percent (%) Relative Humidity
Handling Environment Temperature00 Degrees Celsius
Special Storage Condition, Specify00store below -10 CEL until first use
Storage Environment Humidity0 Percent (%) Relative Humidity0 Percent (%) Relative Humidity
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(877)422-2688xx@xx.xx

Regulatory Flags#

DUNS number
315786293
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
true
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
00380740138332Alinity07P603107P60312020-05-29
00380740192457Alinity06R901A06R901A2020-05-18
00380740170264Alinity09P521A09P521A2020-05-11
00380740170271Alinity09P523A09P523A2020-05-11
00380740121754Alinity08P072108P07212020-05-06
00380740121778Alinity08P073108P07312020-05-06
00380740136574Alinity08P071208P07122020-05-06
00380740146252Alinity08P070208P07022020-05-06
00380740151744Alinity09P411A09P411A2020-05-01
00380740154387Alinity08P073A08P073A2020-05-01
00380740163556ARCHITECT5P56-0205P56022020-05-02
00380740161798ARCHITECT7D79-2207D79222020-04-18
00380740161804ARCHITECT7D79-3207D79322020-04-18
00380740190361ARCHITECT08K280408K28042020-04-15
00380740190378ARCHITECT08K281308K28132020-04-15
00380740154325Alinity09P140309P14032018-07-30
00380740174965ARCHITECT6L45-2206L45222020-04-12
00380740174972ARCHITECT6L45-4206L45422020-04-12
00380740170318Alinity09P551A09P551A2020-03-27
00380740170325Alinity09P553A09P553A2020-03-27

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