BioCheck Human Ferritin EIA Test Kit

Primary DI
00850392007251
Brand
BioCheck Human Ferritin EIA Test Kit
Company
BIOCHECK, INC.
Model
BC-1025
Catalog number
BC-1025
Device description
The BioCheck Human Ferritin EIA Test Kit is intended for the quantitative determination of ferritin 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
DBFFerritin, Antigen, Antiserum, Control

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DBFFerritin, Antigen, Antiserum, ControlImmunology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K992517000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K992517000BIOCHECK FERRITIN ELISA MODEL BC-1025Biocheck, Inc.1999-09-24DBF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850392007251PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850392007251008503920072518503920072510850392007251

GMDN Terms#

Term, Definition table
TermDefinition
Ferritin IVD, kit, enzyme immunoassay (EIA)A collection of reagents and other associated materials intended to be used for the quantitative measurement of ferritin 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
00850392007176BioCheck Myoglobin EIA Test KitBC-1117BC-11172019-10-08
00850392007190BioCheck High Sensitive CRP EIA Test KitBC-1119BC-11192019-10-08
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
00630414293646Atellica IM FerSiemens Healthcare Diagnostics Inc.DBF2020-05-31
00630414294162Atellica IM FerSiemens Healthcare Diagnostics Inc.DBF2020-05-31
03610230007327Yumizen C1200 FerritinHORIBA ABX SASDBF2020-05-06
07613336121238Tina-quant Ferritin Gen.4Roche Diagnostics GmbHDBF2020-03-05
00380740156275ARCHITECTABBOTT LABORATORIESDBF2020-03-03
00380740156329ARCHITECTABBOTT LABORATORIESDBF2020-03-03
04560189212251AIA-PACK FER Calibration Verification Test SetTOSOH CORPORATIONDBF2019-07-25
14560189212258AIA-PACK FER Calibration Verification Test SetTOSOH CORPORATIONDBF2019-07-25
08600000686017Spectro Ferritin MTRamco Laboratories, Inc.DBF2019-03-23
00840239018724Ferritin ELISADRG International IncDBF2019-03-20
00380740131470AlinityABBOTT IRELANDDBF2018-07-31
00380740131487AlinityABBOTT IRELANDDBF2018-07-31
00630414598925Atellica IM FerSiemens Healthcare Diagnostics Inc.DBF2018-02-06
00630414598932Atellica IM FerSiemens Healthcare Diagnostics Inc.DBF2018-02-06
B24225FERHUE010Ferritin ELISAAMERICAN LABORATORY PRODUCTS COMPANY, LTD.DBF2017-08-03
14560189210483ST AIA-PACK FERTOSOH CORPORATIONDBF2016-09-24
15099590011901AUBeckman Coulter, Inc.DBF2016-09-24
B1761380Antiserum to Human FerritinKENT LABORATORIES INCDBF2016-09-24
04560189211452AIA-PACK FER Sample Diluting SolutionTOSOH CORPORATIONDBF2016-09-24
04560189211469ST AIA-PACK FER Calibrator SetTOSOH CORPORATIONDBF2016-09-24
05055273203073FERRRANDOX LABORATORIES LIMITEDDBF2016-09-24
05055273203080FERRRANDOX LABORATORIES LIMITEDDBF2016-09-24
05055273203097FERRRANDOX LABORATORIES LIMITEDDBF2016-09-24
00842768008085N Latex FerritinSiemens Healthcare Diagnostics Products GmbHDBF2016-09-24
00842768015182Dimension Vista® Flex® reagent cartridge FERRSiemens Healthcare Diagnostics Inc.DBF2016-09-24
00857969006167ACEALFA WASSERMANN, INC.DBF2016-09-24
00630414177144ADVIA Centaur® FERSiemens Healthcare Diagnostics Inc.DBF2016-09-24
00630414177151ADVIA Centaur® FERSiemens Healthcare Diagnostics Inc.DBF2016-09-24
00630414204703ADVIA Centaur® FERSiemens Healthcare Diagnostics Inc.DBF2016-09-24
00630414586069ADVIA® Chemistry FRT Ferritin ReagentsSiemens Healthcare Diagnostics Inc.DBF2016-09-24