Alinity

Primary DI: 00380740150679
Brand: Alinity
Company: Abbott GmbH & Co. KG
Model: 09P5720
Catalog number: 09P5720
Device description: Alinity c Complement C4 Reagent Kit 300 Tests
Published: 2019-06-27
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

Related Records

Contact Domains

xx.xx

Product Codes

Code	Name
DBI	COMPLEMENT C4, ANTIGEN, ANTISERUM, CONTROL

Product Code Classifications

Code	Device	Specialty	Class
DBI	Complement C4, Antigen, Antiserum, Control	Immunology	2

Identifiers And Packaging

Identifier	Type	Agency	Package quantity	Status
00380740150679	Primary	GS1	0

Alternate GTIN / UPC / EAN Codes

Source identifier	GTIN-14 normalized	UPC-A	EAN-13
00380740150679	00380740150679	380740150679	0380740150679

GMDN Terms

Term	Definition
Complement components C4/C4c IVD, reagent	A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the quantitative measurement of complement cascade components C4 and/or C4c in a clinical specimen.

Storage And Handling

Type	Low	High	Condition
Handling Environment Temperature	0	30 Degrees Celsius
Storage Environment Temperature	2 Degrees Celsius	8 Degrees Celsius

Sterilization Methods

Method

Contacts

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

Regulatory Flags

DUNS number: 315786293
Device count: 1
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: 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	Catalog	Published
00380740138332	Alinity	07P6031	07P6031	2020-05-29
00380740192457	Alinity	06R901A	06R901A	2020-05-18
00380740170264	Alinity	09P521A	09P521A	2020-05-11
00380740170271	Alinity	09P523A	09P523A	2020-05-11
00380740121754	Alinity	08P0721	08P0721	2020-05-06
00380740121778	Alinity	08P0731	08P0731	2020-05-06
00380740136574	Alinity	08P0712	08P0712	2020-05-06
00380740146252	Alinity	08P0702	08P0702	2020-05-06
00380740151744	Alinity	09P411A	09P411A	2020-05-01
00380740154387	Alinity	08P073A	08P073A	2020-05-01
00380740163556	ARCHITECT	5P56-02	05P5602	2020-05-02
00380740161798	ARCHITECT	7D79-22	07D7922	2020-04-18
00380740161804	ARCHITECT	7D79-32	07D7932	2020-04-18
00380740190361	ARCHITECT	08K2804	08K2804	2020-04-15
00380740190378	ARCHITECT	08K2813	08K2813	2020-04-15
00380740154325	Alinity	09P1403	09P1403	2018-07-30
00380740174965	ARCHITECT	6L45-22	06L4522	2020-04-12
00380740174972	ARCHITECT	6L45-42	06L4542	2020-04-12
00380740170318	Alinity	09P551A	09P551A	2020-03-27
00380740170325	Alinity	09P553A	09P553A	2020-03-27

Other Devices Sharing Product Codes

Primary DI	Brand	Company	Product code	Published
00380740170196	Alinity	ABBOTT IRELAND	DBI	2021-05-13
00380740170202	ARCHITECT	ABBOTT IRELAND	DBI	2021-03-19
00380740175160	ARCHITECT	Abbott GmbH	DBI	2020-11-06
07613336133606	Tina-quant Complement C4 Ver.2	Roche Diagnostics GmbH	DBI	2020-03-05
00630414595658	Atellica CH C4	Siemens Healthcare Diagnostics Inc.	DBI	2017-12-27
15099590010577	AU	Beckman Coulter, Inc.	DBI	2016-09-24
B1761090	Antiserum to Human C-4 (b1e)	KENT LABORATORIES INC	DBI	2016-09-24
B1761092	Anti Human Complement C4 (b1e) FITC	KENT LABORATORIES INC	DBI	2016-09-24
05051700015585	Human C4 Kit for use on SPAPLUS	THE BINDING SITE GROUP LIMITED	DBI	2016-09-24
05051700017602	Optilite C4 Kit	THE BINDING SITE GROUP LIMITED	DBI	2016-09-24
00842768005237	Dimension® Flex® reagent cartridge C4	Siemens Healthcare Diagnostics Inc.	DBI	2016-09-24
00842768006067	Dimension Vista® C4 Complement Flex® reagent cartridge	Siemens Healthcare Diagnostics Products GmbH	DBI	2016-09-24
00842768009693	N Antiserum to Human C4	Siemens Healthcare Diagnostics Products GmbH	DBI	2016-09-24
00842768009709	N Antiserum to Human C4	Siemens Healthcare Diagnostics Products GmbH	DBI	2016-09-24
00630414517742	ADVIA® Chemistry C4 Complement C4 Reagents	Siemens Healthcare Diagnostics Inc.	DBI	2016-09-24
05055273201628	C4	RANDOX LABORATORIES LIMITED	DBI	2016-09-16
05700572002420	Poly Rb A-Hu C4c Complement/FITC	Dako Denmark ApS	DBI	2016-09-16
00816426020085	K-ASSAY® Complement C4 Reagent	KAMIYA BIOMEDICAL COMPANY, LLC	DBI	2016-09-16
00817302020939	CAROLINA LIQUID CHEMISTRIES CORP.® C4 Complement C4 CC635	CAROLINA LIQUID CHEMISTRIES CORPORATION	DBI	2016-09-01
15099590229726	Synchron	Beckman Coulter, Inc.	DBI	2016-08-24
15099590230449	IMMAGE	Beckman Coulter, Inc.	DBI	2016-08-24
10758750006854	VITROS	ORTHO-CLINICAL DIAGNOSTICS, INC.	DBI	2016-08-23
00380740019747	ARCHITECT	ABBOTT LABORATORIES	DBI	2016-06-06