FDA.reportPublic FDA data

IMMCO DIAGNOSTICS

Primary DI
00845714003011
Brand
IMMCO DIAGNOSTICS
Company
IMMCO DIAGNOSTICS, INC.
Model
2100X-8
Catalog number
2100X-8
Device description
IgG FITC Conjugate
Published
2016-09-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LKJAntinuclear Antibody, Antigen, Control

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LKJAntinuclear Antibody, Antigen, ControlImmunology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K883949000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K883949000ANTINUCLEAR ANTIBODY (ANA) TEST (MOUSE LIVER SECT)Immco Diagnostics, Inc.1988-10-27LKJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00845714003011PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00845714003011008457140030118457140030110845714003011

GMDN Terms#

Term, Definition table
TermDefinition
Human immunoglobulin G (IgG) caprine conjugate antibody reagent IVDOne or multiple caprine immunoglobulins (sourced from a goat) intended to be used in combination with other IVDs for the qualitative and/or quantitative detection of antihuman immunoglobulin G (IgG) antibodies. The immunoglobulin molecules are conjugated or bound by additional substances (e.g., fluorescent markers, peroxidase enzymes) for the detection of immune complexes in clinical specimens.

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
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00845714000003IMMCO DIAGNOSTICS110211022016-09-21
00845714000010IMMCO DIAGNOSTICS110311032016-09-21
00845714000089IMMCO DIAGNOSTICS113611362016-09-21
00845714000096IMMCO DIAGNOSTICS1136-961136-962016-09-21
00845714000218IMMCO DIAGNOSTICS117511752016-09-21
00845714000249IMMCO DIAGNOSTICS 1102-601102-602016-09-21
00845714000287IMMCO DIAGNOSTICS110711072016-09-21
00845714000393IMMCO DIAGNOSTICS112511252016-09-21
00845714000430IMMCO DIAGNOSTICS113411342016-09-21
00845714000461IMMCO DIAGNOSTICS1136-2501136-2502016-09-21
00845714000829IMMCO DIAGNOSTICS1102-1201102-1202016-09-21
00845714000836IMMCO DIAGNOSTICS1102-120X1102-120X2016-09-21
00845714000843IMMCO DIAGNOSTICS1102-60X1102-60X2016-09-21
00845714000867IMMCO DIAGNOSTICS 1102X1102X2016-09-21
00845714000874IMMCO DIAGNOSTICS1103-2401103-2402016-09-21
00845714000881IMMCO DIAGNOSTICS 1103-240X1103-240X2016-09-21
00845714000898IMMCO DIAGNOSTICS1103-4801103-4802016-09-21
00845714000904IMMCO DIAGNOSTICS1103-480X1103-480X2016-09-21
00845714000928IMMCO DIAGNOSTICS1103X1103X2016-09-21
00845714001017IMMCO DIAGNOSTICS1107-11107-12016-09-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B3507207900Gold Standard Diagnostics Is-ANA Screen ELISA Test KitGold Standard Diagnostics CorporationLKJ2025-02-26
07333066015545EliA Ro60 WellPhadia ABLKJ2022-09-14
07333066015576EliA Ro52 WellPhadia ABLKJ2022-09-14
07333066014876EliA Ro60 WellPhadia ABLKJ2022-09-14
07333066014906EliA Ro52 WellPhadia ABLKJ2022-09-14
05391516747493ImmcoCLARK LABORATORIES, INC.LKJ2019-12-30
05391516746595Immco DiagnosticsCLARK LABORATORIES, INC.LKJ2019-10-25
00845714003233Immco DiagnosticsIMMCO DIAGNOSTICS, INC.LKJ2018-06-05
04250289503501AESKULISA® ANA HEp-2 Aesku.Diagnostics GmbH & Co. KGLKJ2017-02-28
00845714003219Immco Diagnostics, Inc.IMMCO DIAGNOSTICS, INC.LKJ2017-02-02
00845714004162IMMCO DIAGNOSTICSIMMCO DIAGNOSTICS, INC.LKJ2016-12-09
00845714004179IMMCO DIAGNOSTICSIMMCO DIAGNOSTICS, INC.LKJ2016-12-09
00845714003462IMMCO DIAGNOSTICSIMMCO DIAGNOSTICS, INC.LKJ2016-10-27
00845714004186IMMCO DIAGNOSTICIMMCO DIAGNOSTICS, INC.LKJ2016-10-27
07333066014524EliA U1RNP WellPhadia ABLKJ2016-09-23
07333066014531EliA Sm WellPhadia ABLKJ2016-09-23
07333066014548EliA Ro WellPhadia ABLKJ2016-09-23
07333066014555EliA La WellPhadia ABLKJ2016-09-23
07333066014562EliA CENP WellPhadia ABLKJ2016-09-23
00840733101014ANA Screen ELISA Test KitMERIDIAN BIOSCIENCE, INC.LKJ2016-09-23
07333066010564EliA U1RNP WellPhadia ABLKJ2016-09-23
07333066010571EliA Sm WellPhadia ABLKJ2016-09-23
07333066010588EliA Ro WellPhadia ABLKJ2016-09-23
07333066010595EliA La WellPhadia ABLKJ2016-09-23
07333066010601EliA CENP WellPhadia ABLKJ2016-09-23
00845714001932IMMCO DIAGNOSTICSIMMCO DIAGNOSTICS, INC.LKJ2016-09-23
00845714001949IMMCO DIAGNOSTICSIMMCO DIAGNOSTICS, INC.LKJ2016-09-23
00845714001956IMMCO DIAGNOSTICSIMMCO DIAGNOSTICS, INC.LKJ2016-09-23
00845714001963IMMCO DIAGNOSTICSIMMCO DIAGNOSTICS, INC.LKJ2016-09-23
00845714001970IMMCO DIAGNOSTICSIMMCO DIAGNOSTICS, INC.LKJ2016-09-23