FDA.reportPublic FDA data

IMMCO DIAGNOSTICS

Primary DI
00845714002267
Brand
IMMCO DIAGNOSTICS
Company
IMMCO DIAGNOSTICS, INC.
Model
5129
Catalog number
5129
Device description
SS-B (La) Antibody ELISA
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
LLLExtractable Antinuclear Antibody, Antigen And Control

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LLLExtractable Antinuclear Antibody, Antigen And ControlImmunology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00845714002267PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00845714002267008457140022678457140022670845714002267

GMDN Terms#

Term, Definition table
TermDefinition
SSB/La antibody (Sjogren's antibody) IVD, kit, enzyme immunoassay (EIA)A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of anti-SSB or anti-La antibodies (Sjogren's antibodies) in a clinical specimen, using an enzyme immunoassay (EIA) method.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-800-537-8378info@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 table
Primary DIBrandModelCatalogPublished
00845714002922IMMCO DIAGNOSTICS251425142016-12-09
00845714000935IMMCO DIAGNOSTICS110411042016-09-21
00845714000942IMMCO DIAGNOSTICS 1104X1104X2016-09-21
00845714000959IMMCO DIAGNOSTICS110511052016-09-21
00845714000966IMMCO DIAGNOSTICS1105X1105X2016-09-21
00845714003257IMMCO DIAGNOSTICS221322132016-09-23
00845714003707IMMCO DIAGNOSTICS221622162016-11-16
00845714003714IMMCO DIAGNOSTICS221722172016-09-23
00845714000638IMMCO DIAGNOSTICS1152G1152G2016-09-21
00845714000645IMMCO DIAGNOSTICS1152M1152M2016-09-21
00845714001024IMMCO DIAGNOSTICS1107-1X1107-1X2016-09-21
00845714001994IMMCO DIAGNOSTICS2152-32152-32016-09-23
00845714003332IMMCO DIAGNOSTICS219121912016-09-23
00845714003363IMMCO DIAGNOSTICS219021902016-09-23
00845714003370IMMCO DIAGNOSTICS218921892016-09-23
00845714003387IMMCO DIAGNOSTICS218621862016-09-23
00845714003448IMMCO DIAGNOSTICS2167-82167-82016-09-23
00845714003462IMMCO DIAGNOSTICS250025002016-10-27
00845714003547IMMCO DIAGNOSTICS2152-102152-102016-09-23
00845714003554IMMCO DIAGNOSTICS215421542016-09-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00894175000725AccuDiag™ ENA Profile-6 (Sm/RNP, Sm, Jo-1, Scl-70, SS-A, SS-B) ELISA Diagnostic Automation, Inc.LLL2026-02-27
08430793040051Aptiva® CTD Essential ReagentINOVA DIAGNOSTICS, INC.LLL2023-12-14
04048474039016ENA-6-Profile ELISADRG Instruments Gesellschaft mit beschränkter HaftungLLL2023-08-31
04048474027730ANA Screen IgG ELISA DRG Instruments Gesellschaft mit beschränkter HaftungLLL2023-08-29
00840239039019ENA-6-Profile ELISADRG International IncLLL2023-08-25
00840239035714ENA Screen ELISADRG International IncLLL2023-08-24
00840239027733ANA Screen IgG ELISA DRG International IncLLL2023-08-23
B3507202500Gold Standard Diagnostics Is-anti-SS-A ELISA Test KitGold Standard Diagnostics CorporationLLL2022-12-05
B3507202600Gold Standard Diagnostics Is-anti-SS-B ELISA Test KitGold Standard Diagnostics CorporationLLL2022-12-05
B3507202700Gold Standard Diagnostics Is-anti-Sm/RNP ELISA Test KitGold Standard Diagnostics CorporationLLL2022-12-05
B3507202900Gold Standard Diagnostics Is-anti-Jo-1 ELISA Test KitGold Standard Diagnostics CorporationLLL2022-12-05
B3507202400Gold Standard Diagnostics Is-anti-Sm ELISA Test KitGold Standard Diagnostics CorporationLLL2022-12-03
B3507202800Gold Standard Diagnostics Is-anti-Scl-70 ELISA Test KitGOLD STANDARD DIAGNOSTICS CORP.LLL2020-07-27
07333066016108EliA SymphonyS WellPhadia ABLLL2020-06-30
05391516746854Trinity BiotechCLARK LABORATORIES, INC.LLL2019-12-27
05391516746762Trinity BiotechCLARK LABORATORIES, INC.LLL2019-12-26
05391516746809Trinity BiotechCLARK LABORATORIES, INC.LLL2019-12-26
04048474035711ENA Screen ELISADRG Instruments Gesellschaft mit beschränkter HaftungLLL2019-06-10
00404847435719ENA Screen ELISADRG Instruments Gesellschaft mit beschränkter HaftungLLL2019-06-10
04250289502924AESKULISA® ENA-6S Aesku.Diagnostics GmbH & Co. KGLLL2017-02-28
04250289500449AESKULISA® ENA-6S Aesku.Diagnostics GmbH & Co. KGLLL2016-09-27
00816879020144Autostat II ENA-6 ScreenHYCOR BIOMEDICAL LLCLLL2016-09-26
00816879020298Autostat II Anti-SS-A/RoHYCOR BIOMEDICAL LLCLLL2016-09-26
00816879020304Autostat II Anti-SS-B/LaHYCOR BIOMEDICAL LLCLLL2016-09-26
00816879020335Autostat II Anti-Jo-1HYCOR BIOMEDICAL LLCLLL2016-09-26
00816879020342Autostat II Anti-Scl-70HYCOR BIOMEDICAL LLCLLL2016-09-26
00816879020380Autostat II Anti-ENA-6 ProfileHYCOR BIOMEDICAL LLCLLL2016-09-26
04049016027034Anti-SS-A ELISA (IgG)EUROIMMUN Medizinische Labordiagnostika AGLLL2016-09-24
04049016027041Anti-SS-B ELISA (IgG)EUROIMMUN Medizinische Labordiagnostika AGLLL2016-09-24
04049016027058Anti-Scl-70 ELISA (IgG)EUROIMMUN Medizinische Labordiagnostika AGLLL2016-09-24