FDA.reportPublic FDA data

Myoglobin ELISA

Primary DI
00840239039552
Brand
Myoglobin ELISA
Company
DRG International Inc
Model
EIA-3955
Catalog number
EIA-3955
Device description
The Myoglobin ELISA is intended for the quantitative determination of myoglobin in human serum.
Published
2019-06-10
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

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
00840239039552PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840239039552008402390395528402390395520840239039552

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.

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(973)564-7555corp@drg-international.com

Regulatory Flags#

DUNS number
075150847
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
00840239041173ANA Detect ELISAEIA-4117EIA-41172023-08-25
00840239035622ANA-8-Screen ELISAEIA-3562EIA-35622023-08-24
00840239035639ANA-8-Profile ELISAEIA-3563EIA-35632023-08-24
00840239027733ANA Screen IgG ELISA EIA-2773EIA-27732023-08-23
00840239035899Anti-Cardiolipin Screen ELISAEIA-3589EIA-35892023-08-25
00840239035967c-ANCA (PR3) ELISAEIA-3596EIA-35962023-08-25
00840239036025Anti-Lactoferrin ELISAEIA-3602EIA-36022023-08-25
00840239059673Measles Virus IgG Avidity ELISAEIA-5967EIA-59672023-08-26
00840239060594Giardia/Cryptosporidium Ag (stool) ELISA EIA-6059EIA-60592023-08-26
00840239027931Epstein Barr Virus VCA IgG ELISAEIA-2793EIA-27932023-08-24
00840239027948Epstein Barr Virus VCA IgM ELISAEIA-2794EIA-27942023-08-24
00840239027962EBV-EA IgG ELISAEIA-2796EIA-27962023-08-24
00840239028150H. Pylori IgG ELISA EIA-2815EIA-28152023-08-24
00840239033710Gliadin IgG ELISA EIA-3371EIA-33712023-08-24
00840239034670Cryptosporidium Antigen (stool) ELISA EIA-3467EIA-34672023-08-24
00840239034731Entamoeba histolytica Ag (stool) ELISA EIA-3473EIA-34732023-08-24
00840239034779Giardia lamblia Antigen (stool) ELISA EIA-3477EIA-34772023-08-24
00840239035523HGH (Human Growth Hormone) ELISAEIA-3552EIA-35522023-08-24
00840239035615Anti TPO Ab ELISAEIA-3561EIA-35612023-08-24
00840239035646Anti-dsDNA IgM ELISAEIA-3564EIA-35642023-08-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04048474039559Myoglobin ELISADRG Instruments Gesellschaft mit beschränkter HaftungDRR2023-08-31
00083059070309Myoglobin Enzyme Immunoassay Test KitBIOMERICA, INC.DRR2020-07-01
00850392007176BioCheck Myoglobin EIA Test KitBIOCHECK, INC.DRR2019-10-08
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