FDA.reportPublic FDA data

Myoglobin Enzyme Immunoassay Test Kit

Primary DI
00083059070309
Brand
Myoglobin Enzyme Immunoassay Test Kit
Company
BIOMERICA, INC.
Model
7030
Device description
The Myoglobin ELISA is intended for the quantitative determination of myoglobin in human serum.
Published
2020-07-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
DRRAmplifier And Signal Conditioner, Biopotential

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DRRAmplifier And Signal Conditioner, BiopotentialCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K022660000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K022660000BIOCHECK MYOGLOBIN ELISA, MODEL BC-1117Biocheck, Inc.2002-12-19DRR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00083059070309PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00083059070309000830590703090830590703090083059070309

GMDN Terms#

Term, Definition table
TermDefinition
Myoglobin IVD, kit, enzyme immunoassay (EIA)A collection of reagents and other associated materials intended to be used for the quantitative measurement of myoglobin in a clinical specimen, using an enzyme immunoassay (EIA) method.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1 949 645 2111info@biomerica.com

Regulatory Flags#

DUNS number
067647321
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

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08305900070316TROPONIN I (HUMAN CARDIAC-SPECIFIC) ENZYME IMMUNOASSAY TEST KIT70312016-12-08
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Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04048474039559Myoglobin ELISADRG Instruments Gesellschaft mit beschränkter HaftungDRR2023-08-31
00850392007176BioCheck Myoglobin EIA Test KitBIOCHECK, INC.DRR2019-10-08
00840239039552Myoglobin ELISADRG International IncDRR2019-06-10
08305900070309Myoglobin Enzyme Immunoassay Test KitBIOMERICA, INC.DRR2016-12-07
00811727013354Pointe Scientific, Inc.HORIBA INSTRUMENTS INCORPORATEDDRR2016-08-31
00840682119603CLAB II Plus AmplifierGE Medical Systems Information Technologies, Inc.DRR2016-07-03
00840682119634CLAB II Plus AmplifierGE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.DRR2016-07-03