FDA.reportPublic FDA data

BioCheck Myoglobin EIA Test Kit

Primary DI
00850392007176
Brand
BioCheck Myoglobin EIA Test Kit
Company
BIOCHECK, INC.
Model
BC-1117
Catalog number
BC-1117
Device description
The BioCheck Myoglobin EIA Test Kit is intended for the quantitative determination of myoglobin in human serum.
Published
2019-10-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
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
00850392007176PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850392007176008503920071768503920071760850392007176

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
(650)573-1968info@biocheckinc.com

Regulatory Flags#

DUNS number
171857493
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850392007015BioCheck TSH EIA Test KitBC-1001BC-10012019-10-08
00850392007039BioCheck U-TSH EIA Test KitBC-1003BC-10032019-10-08
00850392007053BioCheck T3 EIA Test KitBC-1005BC-10052019-10-08
00850392007077BioCheck T4 EIA Test KitBC-1007BC-10072019-10-08
00850392007190BioCheck High Sensitive CRP EIA Test KitBC-1119BC-11192019-10-08
00850392007251BioCheck Human Ferritin EIA Test KitBC-1025BC-10252019-10-08
00850392007275BioCheck hCG EIA Test KitBC-1027BC-10272019-10-08
00850392007350BioCheck IgE EIA Test KitBC-1035BC-10352019-10-08
00850392007619BioCheck Beta-2 Microglobulin EIA Test KitBC-1061BC-10612019-10-08
00850392007152BioCheck Testosterone EIA Test KitBC-1115BC-11152019-07-30

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
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