FDA.reportPublic FDA data

Alinity

Primary DI
00380740132699
Brand
Alinity
Company
Abbott GmbH & Co. KG
Model
04R1001
Catalog number
04R1001
Device description
Alinity ci-series Calibrator/Control Replacement Caps
Published
2018-05-31
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
JJEANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JJEAnalyzer, Chemistry (Photometric, Discrete), For Clinical UseClinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00380740132699PrimaryGS10
00380740163495Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00380740132699003807401326993807401326990380740132699
00380740163495003807401634953807401634950380740163495

GMDN Terms#

Term, Definition table
TermDefinition
Multiple clinical chemistry analyser IVD, laboratory, automatedAn electrically-powered laboratory instrument intended to be used for the qualitative and/or quantitative in vitro determination of multiple clinical chemistry analytes in a clinical specimen. Analytes detected may include electrolytes, specific proteins, lipids and kidney, liver and/or cardiac function test analytes. The analyser typically requires analyte specific test kits or reagents, using one or more technologies which may include microfluidics, electrometry, spectrophotometry, fluorimetry, radiometry and/or chemiluminescence. The device operates with minimal technician involvement and complete automation of all procedural steps.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Humidity0 Percent (%) Relative Humidity0 Percent (%) Relative Humidity
Storage Environment Temperature2 Degrees Celsius40 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
100
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
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
07613336200544cobas c 703 analytical unitRoche Diagnostics GmbHJJE2026-03-20
07613336220191cobas pro SBL c 703Roche Diagnostics GmbHJJE2026-03-20
00199874508153Spiral LaboratoriesSOCIETE ANONYME DE FABRICATION D'APPAREILS SCIENTIFIQUESJJE2026-02-10
00380740023386ARCHITECTABBOTT LABORATORIESJJE2026-01-24
00380740225155ARCHITECTABBOTT LABORATORIESJJE2026-01-03
00380740225162ARCHITECTABBOTT LABORATORIESJJE2026-01-03
00380740223748AlinityAbbott GmbHJJE2026-01-01
00380740224523ARCHITECTABBOTT LABORATORIESJJE2026-01-01
00380740224530ARCHITECTABBOTT LABORATORIESJJE2026-01-01
00380740186241AlinityAbbott GmbHJJE2025-12-19
00380740186258AlinityAbbott GmbHJJE2025-12-19
00380740213398AlinityAbbott GmbHJJE2025-12-19
00380740213404AlinityAbbott GmbHJJE2025-12-19
00380740213411AlinityAbbott GmbHJJE2025-12-19
00380740213428AlinityAbbott GmbHJJE2025-12-19
00380740199074AlinityAbbott GmbHJJE2025-11-27
00380740215224AlinityAbbott GmbHJJE2025-09-29
04260678680010GEMINISTRATEC SEJJE2025-09-05
00380740220556ARCHITECTABBOTT LABORATORIESJJE2025-08-22
00380740220563ARCHITECTABBOTT LABORATORIESJJE2025-08-22
00380740220495ARCHITECTABBOTT LABORATORIESJJE2025-08-02
00380740220501ARCHITECTABBOTT LABORATORIESJJE2025-08-02
05999883586419P780 Clinical Chemistry Analyzer with ISE moduleDiatron Medicinai Instrumentumok Laboratoriumi Diagnosztikai Fejleszto-Gyarto Zartkoruen Mukodo ReszvenytarsasagJJE2025-07-10
05999883586426P780 Clinical Chemistry AnalyzerDiatron Medicinai Instrumentumok Laboratoriumi Diagnosztikai Fejleszto-Gyarto Zartkoruen Mukodo ReszvenytarsasagJJE2025-07-10
05999883586907Atellica DT Cuvettes (280pcs)Diatron Medicinai Instrumentumok Laboratoriumi Diagnosztikai Fejleszto-Gyarto Zartkoruen Mukodo ReszvenytarsasagJJE2025-06-13
10758750035656VITROSORTHO-CLINICAL DIAGNOSTICS, INC.JJE2025-05-21
03701700860358Viva-ProEVitalScientific B.V.JJE2025-04-30
15999883586744Atellica DT 250 Analyzer Diatron Medicinai Instrumentumok Laboratoriumi Diagnosztikai Fejleszto-Gyarto Zartkoruen Mukodo ReszvenytarsasagJJE2025-04-30
00380740186425AlinityAbbott GmbHJJE2025-04-15
00380740190644ARCHITECTABBOTT LABORATORIESJJE2025-04-15