Atellica IM Zika IgM 50T

Contact Domains#

Code, Name table
Code	Name
QFO	Zika virus serological reagents

Code, Device, Specialty table
Code	Device	Specialty	Class
QFO	Zika Virus Serological Reagents	Microbiology	2

Submission, Supplement table
Submission	Supplement
K191578	000

Submission, Supplement, Device table
Submission	Supplement	Device	Applicant	Decision date	Product code
K191578	000	ADVIA Centaur Zika test, ADVIA Centaur Zika Ab (100 tests), ADVIA Centaur Zika IgM (50 tests), ADVIA Centaur Zika Ab Quality Control, ADVIA Centaur Zika IgM Quality Control	Siemens Healthcare Diagnostics, Inc.	2019-07-17	QFO

Identifier, Type, Agency table
Identifier	Type	Agency	Package quantity	Status
00630414286839	Primary	GS1	0

Source identifier, GTIN-14 normalized, UPC-A table
Source identifier	GTIN-14 normalized	UPC-A	EAN-13
00630414286839	00630414286839	630414286839	0630414286839

Term, Definition table
Term	Definition
Zika virus immunoglobulin M (IgM) antibody IVD, kit, chemiluminescent immunoassay	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of immunoglobulin M (IgM) antibodies to Zika virus in a clinical specimen, using a chemiluminescent immunoassay method.

Type, Low, High table
Type	Low	High	Condition
Handling Environment Temperature	2 Degrees Celsius	8 Degrees Celsius
Special Storage Condition, Specify	0	0	Store upright, Protect from Light, Do not freeze, Resuspend.
Storage Environment Temperature	2 Degrees Celsius	8 Degrees Celsius

Method table
Method

Phone, Email table
Phone	Email
+1(877)229-3711	XX@XX.XX
+1(877)229-3711	CONTACT@SIEMENS-HEALTHINEERS.COM

Primary DI, Brand, Model table
Primary DI	Brand	Model	Catalog	Published
00630414596167	Atellica CH ASO_2	11097634	11097634	2020-09-24
00630414596259	Atellica CH PreAlb	11097617	11097617	2020-09-24
00630414596440	Atellica CH GGT	11097597	11097597	2020-09-24
00630414596174	Atellica CH hsCRP	11097633	11097633	2017-12-21
00630414596198	Atellica CH CRP_2	11097631	11097631	2017-12-27
00630414597508	Atellica CH hsCRP Calibrator	11099412	11099412	2017-12-22
00630414597515	Atellica CH CRP_2 Calibrator	11099430	11099430	2017-12-22
00630414611075	Atellica CH Crea3	11537215	11537215	2026-05-08
00630414611297	Atellica CH RCRP Cal	11537245	11537245	2024-02-02
00842768037726	Dimension EXL LOCI Troponin I High Sensitive	10471068	10471068	2019-10-16
00630414596099	Atellica CH Thc	11097503	11097503	2017-12-27
00630414510156	ADVIA® Chemistry PAMY Pancreatic Amylase Reagents	10315178	1410820	2016-09-24
00630414595641	Atellica CH PAmy	11097622	11097622	2017-12-21
00630414608273	ADVIA Centaur Tumor Marker Quality Control (TM QC)	11538186	11538186	2026-05-29
00630414622859	Atellica IM Tumor Marker Quality Control (TM QC)	11538187	11538187	2026-05-29
00630414517681	ADVIA® Chemistry ASO_2 Anti-Streptolysin-O_2 Reagents	10318208	3055483	2020-09-24
00842768016912	Dimension® PBNP Calibrator	10445008	RC423A	2016-09-24
00630414498942	ADVIA® Chemistry ACET Acetaminophen Reagents	10327381	7989138	2016-09-24
00630414568768	ADVIA® Chemistry BENZ_2 Benzodiazepine_2 Reagents	10378760	10378760	2016-09-24
00630414653259	Atellica CH Crea3	11537567	11537567	2026-05-08

Primary DI, Brand, Company table
Primary DI	Brand	Company	Product code	Published
00607158000106	DPP Zika IgM System	Chembio Diagnostic Systems Inc.	QFO	2020-08-06
00630414247007	ADVIA Centaur Zika IgM 50T	Siemens Healthcare Diagnostics Inc.	QFO	2020-02-24
00630414247021	ADVIA Centaur Zika Ab 100T	Siemens Healthcare Diagnostics Inc.	QFO	2020-02-24
00630414286853	Atellica IM Zika Ab 100T	Siemens Healthcare Diagnostics Inc.	QFO	2020-02-24
08056771602624	LIAISON® XL Zika Capture IgM II	Diasorin Inc.	QFO	2019-12-04
B379ZKM21	ZIKV Detect™ 2.0 IgM Capture ELISA	INBIOS INTERNATIONAL, INC	QFO	2019-05-24