IMMCO DIAGNOSTICS

Primary DI: 00845714001031
Brand: IMMCO DIAGNOSTICS
Company: IMMCO DIAGNOSTICS, INC.
Model: 1107-2
Catalog number: 1107-2
Device description: Autoantibody Test Reagent Pack - Mouse Kidney Substrate
Published: 2016-09-21
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: false

Related Records

Contact Domains

immco.com

Product Codes

Code	Name
LKJ	Antinuclear Antibody, Antigen, Control

Product Code Classifications

Code	Device	Specialty	Class
LKJ	Antinuclear Antibody, Antigen, Control	Immunology	2

Identifiers And Packaging

Identifier	Type	Agency	Package quantity	Status
00845714001031	Primary	GS1	0

Alternate GTIN / UPC / EAN Codes

Source identifier	GTIN-14 normalized	UPC-A	EAN-13
00845714001031	00845714001031	845714001031	0845714001031

GMDN Terms

Term	Definition
Multiple antinuclear antibody (ANA) screening IVD, kit, fluorescent immunoassay	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative screening for one or multiple antinuclear antibodies (ANA) in a clinical specimen, using a fluorescent immunoassay method.

Device Sizes

Type	Value	Unit
Device Size Text, specify	0

Storage And Handling

Type	Low	High	Condition
Storage Environment Temperature	2 Degrees Celsius	8 Degrees Celsius

Sterilization Methods

Method

Contacts

Phone	Email
1-800-537-8378	INFO@IMMCO.COM

Regulatory Flags

DUNS number: 079935300
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: true
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
00845714002922	IMMCO DIAGNOSTICS	2514	2514	2016-12-09
00845714000935	IMMCO DIAGNOSTICS	1104	1104	2016-09-21
00845714000942	IMMCO DIAGNOSTICS	1104X	1104X	2016-09-21
00845714000959	IMMCO DIAGNOSTICS	1105	1105	2016-09-21
00845714000966	IMMCO DIAGNOSTICS	1105X	1105X	2016-09-21
00845714003257	IMMCO DIAGNOSTICS	2213	2213	2016-09-23
00845714003707	IMMCO DIAGNOSTICS	2216	2216	2016-11-16
00845714003714	IMMCO DIAGNOSTICS	2217	2217	2016-09-23
00845714000638	IMMCO DIAGNOSTICS	1152G	1152G	2016-09-21
00845714000645	IMMCO DIAGNOSTICS	1152M	1152M	2016-09-21
00845714001024	IMMCO DIAGNOSTICS	1107-1X	1107-1X	2016-09-21
00845714001994	IMMCO DIAGNOSTICS	2152-3	2152-3	2016-09-23
00845714003332	IMMCO DIAGNOSTICS	2191	2191	2016-09-23
00845714003363	IMMCO DIAGNOSTICS	2190	2190	2016-09-23
00845714003370	IMMCO DIAGNOSTICS	2189	2189	2016-09-23
00845714003387	IMMCO DIAGNOSTICS	2186	2186	2016-09-23
00845714003448	IMMCO DIAGNOSTICS	2167-8	2167-8	2016-09-23
00845714003462	IMMCO DIAGNOSTICS	2500	2500	2016-10-27
00845714003547	IMMCO DIAGNOSTICS	2152-10	2152-10	2016-09-23
00845714003554	IMMCO DIAGNOSTICS	2154	2154	2016-09-23

Other Devices Sharing Product Codes

Primary DI	Brand	Company	Product code	Published
B3507207900	Gold Standard Diagnostics Is-ANA Screen ELISA Test Kit	Gold Standard Diagnostics Corporation	LKJ	2025-02-26
07333066014876	EliA Ro60 Well	Phadia AB	LKJ	2022-09-14
07333066014906	EliA Ro52 Well	Phadia AB	LKJ	2022-09-14
05391516747493	Immco	CLARK LABORATORIES, INC.	LKJ	2019-12-30
05391516746595	Immco Diagnostics	CLARK LABORATORIES, INC.	LKJ	2019-10-25
00845714003233	Immco Diagnostics	IMMCO DIAGNOSTICS, INC.	LKJ	2018-06-05
00845714003219	Immco Diagnostics, Inc.	IMMCO DIAGNOSTICS, INC.	LKJ	2017-02-02
00840733101014	ANA Screen ELISA Test Kit	MERIDIAN BIOSCIENCE, INC.	LKJ	2016-09-23
07333066010564	EliA U1RNP Well	Phadia AB	LKJ	2016-09-23
07333066010571	EliA Sm Well	Phadia AB	LKJ	2016-09-23
07333066010588	EliA Ro Well	Phadia AB	LKJ	2016-09-23
07333066010595	EliA La Well	Phadia AB	LKJ	2016-09-23
07333066010601	EliA CENP Well	Phadia AB	LKJ	2016-09-23
00845714001949	IMMCO DIAGNOSTICS	IMMCO DIAGNOSTICS, INC.	LKJ	2016-09-23
00845714001956	IMMCO DIAGNOSTICS	IMMCO DIAGNOSTICS, INC.	LKJ	2016-09-23
00845714001963	IMMCO DIAGNOSTICS	IMMCO DIAGNOSTICS, INC.	LKJ	2016-09-23
00845714001970	IMMCO DIAGNOSTICS	IMMCO DIAGNOSTICS, INC.	LKJ	2016-09-23
00845714003011	IMMCO DIAGNOSTICS	IMMCO DIAGNOSTICS, INC.	LKJ	2016-09-23
00845714003223	IMMCO DIAGNOSTICS	IMMCO DIAGNOSTICS, INC.	LKJ	2016-09-23
00845714003226	IMMCO DIAGNOSTICS	IMMCO DIAGNOSTICS, INC.	LKJ	2016-09-23
00845714003448	IMMCO DIAGNOSTICS	IMMCO DIAGNOSTICS, INC.	LKJ	2016-09-23
00845714003530	IMMCO DIAGNOSTICS	IMMCO DIAGNOSTICS, INC.	LKJ	2016-09-23
00845714004322	IMMCO DIAGNOSTICS	IMMCO DIAGNOSTICS, INC.	LKJ	2016-09-23
00845714004339	IMMCO DIAGNOSTICS	IMMCO DIAGNOSTICS, INC.	LKJ	2016-09-23
00845714000003	IMMCO DIAGNOSTICS	IMMCO DIAGNOSTICS, INC.	LKJ	2016-09-21
00845714000010	IMMCO DIAGNOSTICS	IMMCO DIAGNOSTICS, INC.	LKJ	2016-09-21
00845714000249	IMMCO DIAGNOSTICS	IMMCO DIAGNOSTICS, INC.	LKJ	2016-09-21
00845714000829	IMMCO DIAGNOSTICS	IMMCO DIAGNOSTICS, INC.	LKJ	2016-09-21
00845714000836	IMMCO DIAGNOSTICS	IMMCO DIAGNOSTICS, INC.	LKJ	2016-09-21
00845714000843	IMMCO DIAGNOSTICS	IMMCO DIAGNOSTICS, INC.	LKJ	2016-09-21