FDA.reportPublic FDA data

Direct TIBC Calibrators

Primary DI
00817439021274
Brand
Direct TIBC Calibrators
Company
Medtest Dx, Inc.
Model
TIBCC480
Catalog number
TIBCC480
Device description
For calibrating the quantitative Direct Total Iron-Binding Capacity (TIBC) assay on automated chemistry analyzer systems. 2 x 1ml.
Published
2016-09-27
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
JITCalibrator, Secondary

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JITCalibrator, SecondaryClinical Chemistry2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K052148000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K052148000TOTAL IRON-BINDING CAPACITY CALIBRATOR SET. DIRECT TIBC CALIBRATOR SETReference Diagnostics, Inc.2005-11-09JIT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00817439021274PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817439021274008174390212748174390212740817439021274

GMDN Terms#

Term, Definition table
TermDefinition
Total iron binding capacity (TIBC) IVD, calibratorA material which is used to establish known points of reference for an assay intended to be used for the quantitative measurement of total iron binding capacity (TIBC) of a clinical specimen.

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
800-445-9853techservice@medtest.com

Regulatory Flags#

DUNS number
070371210
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
00817439020000Direct Lipid Control Set300030002016-09-27
00817439020017Direct Lipid Control L1300130012016-09-27
00817439020024Direct Lipid Control L2300230022016-09-27
00817439020031Direct Lipid Control L3300330032016-09-27
00817439020062Wash Concentrate 103W50003W5002016-09-27
00817439020079Wash Concentrate 209W50009W5002016-09-27
00817439020086Wash Concentrate 310W50010W5002016-09-27
00817439020093Albumin / BS480ALB480ALB4802016-09-27
00817439020109AlbuminALB505ALB5052016-09-27
00817439020116Albumin / BS200ALB600ALB6002016-09-27
00817439020123Alkaline Phos/ BS480ALP480ALP4802016-09-27
00817439020130ALP ReagentALP505ALP5052016-09-27
00817439020147MedTest DX Alkaline PhosphataseALP600ALP6002016-09-27
00817439020192Amylase / BS480AMY480AMY4802016-09-27
00817439020215Amylase / BS200AMY600AMY6002016-09-27
00817439020222AST / BS480AST480AST4802016-09-27
00817439020239AST / Polychem 180AST505AST5052016-09-27
00817439020246AST / BS200AST600AST6002016-09-27
00817439020314C1 Cleaning SolutionC1S500C1S5002016-09-27
00817439020321Calibrator Level 1 CA1100CA11002016-09-30

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