FDA.reportPublic FDA data

Trinity Biotech

Primary DI
05391516746359
Brand
Trinity Biotech
Company
MARDX DIAGNOSTICS, INC.
Model
1206621
Catalog number
1206621
Device description
Uni-Gold™ Cryptosporidium Control, Cryptosporidium Positive and Negative Control, 1 Positive and 1 Negative
Published
2016-09-18
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MHJCryptosporidium Spp.

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MHJCryptosporidium Spp.Microbiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K121565000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K121565000UNI-GOLD CRYPTOSPORIDIUMTrinity Biotech2013-02-08MHJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05391516746359PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05391516746359053915167463595391516746359

GMDN Terms#

Term, Definition table
TermDefinition
Cryptosporidium parvum immunoglobulin G (IgG) antibody IVD, controlA material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of immunoglobulin G (IgG) antibodies to the parasitic protozoan Cryptosporidium parvum in a clinical specimen.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius25 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
800-325-3424info@trinitybiotech.com

Regulatory Flags#

DUNS number
154281349
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05391516747585Trinity Biotech90-160790-16072016-09-18
05391516747943Trinity Biotech90-161090-16102016-09-19
05391516748698Trinity Biotech20-0464820-046482016-09-18
05391516748919Trinity Biotech20-0400620-040062016-09-18
05391516748926Trinity Biotech20-0400220-040022016-09-18
05391516747851Trinity Biotech40-3025G40-3025G2016-09-18
05391516746182Trinity Biotech32-5100G32-5100G2016-09-18
05391516746199Trinity Biotech32-5100M32-5100M2016-09-18
05391516747721Trinity Biotech40-101340-10132016-09-19
05391516747738Trinity Biotech41-900241-90022016-09-19
05391516748735Trinity Biotech44-2020GV44-2020GV2016-09-18
05391516748742Trinity Biotech44-2020M44-2020M2016-09-19
05391516746151Trinity Biotech30-712030-71202016-09-18
05391516746168Trinity Biotech30-718030-71802016-09-18
05391516746175Trinity Biotech30-736030-73602016-09-18
05391516746205Trinity Biotech40-2075G40-2075G2016-09-18
05391516746212Trinity Biotech40-2075M40-2075M2016-09-18
05391516746229Trinity Biotech40-5065G40-5065G2016-09-18
05391516746236Trinity Biotech40-5065G/B40-5065G/B2016-09-18
05391516746243Trinity Biotech40-5065M40-5065M2016-09-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04048474060591Giardia/Cryptosporidium Ag (stool) ELISA DRG Instruments Gesellschaft mit beschränkter HaftungMHJ2023-09-01
04048474034677Cryptosporidium Antigen (stool) ELISA DRG Instruments Gesellschaft mit beschränkter HaftungMHJ2023-08-29
00840239034670Cryptosporidium Antigen (stool) ELISA DRG International IncMHJ2023-08-24
00083059070637Cryptosporidium ELISA [Enzyme-Linked ImmunoSorbent Assay]BIOMERICA, INC.MHJ2020-07-01
00857031002547TRI-COMBO PARASITE SCREENTECHLAB, INC.MHJ2019-05-31
00857031002400TRI-COMBO PARASITE SCREENTECHLAB, INC.MHJ2017-10-05
08305900070637Cryptosporidium ELISA [Enzyme-Linked ImmunoSorbent Assay]BIOMERICA, INC.MHJ2016-12-08
00848838026898NAREMEL, INC.MHJ2016-09-24
00848838026904NAREMEL, INC.MHJ2016-09-24
00848838026935NAOXOID LIMITEDMHJ2016-09-24
00893038002180Triage®Alere San Diego, Inc.MHJ2016-09-21
M445MCCCGDFA750Para-Tect Cryptosporidium/Giardia Direct Fluorescence AssayMEDICAL CHEMICAL CORPORATIONMHJ2016-09-20
05391516746342TrinityBiotechMARDX DIAGNOSTICS, INC.MHJ2016-09-18
00857031002035CRYPTOSPORIDIUM IITECHLAB, INC.MHJ2016-08-23
00857031002127GIARDIA/CRYPTOSPORIDIUM CHEKTECHLAB, INC.MHJ2016-08-23
00857031002240GIARDIA/CRYPTOSPORIDIUM CHEKTECHLAB, INC.MHJ2016-08-23
00857031002301CRYPTOSPORIDIUM IITECHLAB, INC.MHJ2016-08-23