FDA.reportPublic FDA data

Immco Diagnostics, Inc.

Primary DI
00845714004704
Brand
Immco Diagnostics, Inc.
Company
IMMCO DIAGNOSTICS, INC.
Model
6101G-50
Catalog number
6101G-50
Device description
Lyme B. burgdorferi (IgG) Marstripe Test
Published
2017-02-06
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
LSRReagent, Borrelia Serological Reagent

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LSRReagent, Borrelia Serological ReagentMicrobiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K163095000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K163095000Lyme B. burgdorferi (IgG) MarStripe TestTrinity Biotech2017-02-01LSR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00845714004704PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00845714004704008457140047048457140047040845714004704

GMDN Terms#

Term, Definition table
TermDefinition
Multiple clinical chemistry protein IVD, kit, immunoblotA collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of one or multiple clinical chemistry proteins in a clinical specimen, using an immunoblot 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
Kit
true
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
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00850049545259AccuDiag ™Diagnostic Automation, Inc.LSR2024-03-06
00850054026378QMedix™Diagnostic Automation, Inc.LSR2024-01-31
04048474028096B. burgdorferi IgG/IgM ELISADRG Instruments Gesellschaft mit beschränkter HaftungLSR2023-08-29
04048474028102Borrelia burgdorferi IgG (Lyme) ELISADRG Instruments Gesellschaft mit beschränkter HaftungLSR2023-08-29
04048474028119Borrelia burgdorferi IgM (Lyme) ELISA DRG Instruments Gesellschaft mit beschränkter HaftungLSR2023-08-29
00840239028099B. burgdorferi IgG/IgM ELISADRG International IncLSR2023-08-24
00840239028105Borrelia burgdorferi IgG (Lyme) ELISADRG International IncLSR2023-08-24
00840239028112Borrelia burgdorferi IgM (Lyme) ELISA DRG International IncLSR2023-08-24
EVIRBTCFDK1Borrelia All-In-One ViraChip Deca KitViramed Biotech AGLSR2022-11-08
EVIRBTCFOK1Borrelia All-In-One ViraChip Test KitViramed Biotech AGLSR2022-11-08
B350GSD0110310Gold Standard Diagnostics Borrelia burgdorferi IgG/IgM ELISA Test KitGold Standard Diagnostics CorporationLSR2022-10-28
B350GSD0110250Gold Standard Diagnostics Borrelia burgdorferi IgG ELISA Test KitGold Standard Diagnostics CorporationLSR2022-09-24
B350GSD0110260Gold Standard Diagnostics Borrelia burgdorferi IgM ELISA Test KitGold Standard Diagnostics CorporationLSR2022-09-24
00845533001854ELISA Borrelia VlsE1/pepC10 IgG/IgM Smart Kit Test SystemZEUS SCIENTIFIC, INC.LSR2022-04-27
00894175000022AccuDiag ™ Diagnostic Automation, Inc.LSR2021-08-10
B350GSD0110270Gold Standard Diagnostics Borrelia burgdorferi VIsE-OspC ELISA IgG/ IgM Test KitGold Standard Diagnostics CorporationLSR2021-07-20
B350GSD0110220Gold Standard Diagnostics Borrelia burgdorferi B31 IgG Line Blot Test KitGold Standard Diagnostics CorporationLSR2020-07-01
B350GSD0110230Gold Standard Diagnostics Borrelia burgdorferi B31 IgM Line Blot Test KitGold Standard Diagnostics CorporationLSR2020-07-01
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30014613337799SofiaQUIDEL CORPORATIONLSR2019-12-10
05391516747486Trinity BiotechCLARK LABORATORIES, INC.LSR2019-11-05
05391516746625MarDxCLARK LABORATORIES, INC.LSR2019-10-25
05391516747134Trinity BiotechCLARK LABORATORIES, INC.LSR2019-08-06
05391516747547Trinity BiotechCLARK LABORATORIES, INC.LSR2019-08-06
03610520506394BioPlex 2200BIO-RAD LABORATORIES, INC.LSR2019-05-13
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30014613202981SofiaQUIDEL CORPORATIONLSR2018-08-07