FDA.reportPublic FDA data

MAGICL T3 (CLIA)

Primary DI
06954414731316
Brand
MAGICL T3 (CLIA)
Company
Getein Biotech,Inc
Model
CLIA3006A
Catalog number
CLIA3006A
Published
2026-07-10
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06954414731316PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06954414731316069544147313166954414731316

GMDN Terms#

Term, Definition table
TermDefinition
Total triiodothyronine (TT3) IVD, kit, chemiluminescent immunoassayA collection of reagents and other associated materials intended to be used for the quantitative measurement of total triiodothyronine (TT3) in a clinical specimen, using a chemiluminescent immunoassay method.

Regulatory Flags#

DUNS number
542973494
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
true
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
06954414726404T3 Fast Test Kit (Immunofluorescence Assay)IF1022IF10222026-07-10
06954414726411T3 Fast Test Kit (Immunofluorescence Assay)IF1022IF10222026-07-10
06954414726428T4 Fast Test Kit (Immunofluorescence Assay)IF10232026-07-10
06954414726435T4 Fast Test Kit (Immunofluorescence Assay)IF10232026-07-10
06954414728125MAGICL FT3 (CLIA)CLIA3008ACLIA3008A2026-07-10
06954414728385MAGICL Tg (CLIA)CLIA3074A2026-07-10
06954414728583MAGICL Tg (CLIA)CLIA3074A2026-07-10
06954414728811MAGICL FT3 (CLIA)CLIA3008ACLIA3008A2026-07-10
06954414731101MAGICL T3 (CLIA)CLIA3006ACLIA3006A2026-07-10
06954414731118MAGICL T4 (CLIA)CLIA3007A2026-07-10
06954414731323MAGICL T4 (CLIA)CLIA3007A2026-07-10
06954414731682MAGICL Tg (CLIA)CLIA3074A2026-07-10
06954414734072MAGICL Tg (CLIA)CLIA3074A2026-07-10
06954414735123T3 Fast Test Kit (Immunofluorescence Assay)IF2022IF20222026-07-10
06954414735147T4 Fast Test Kit (Immunofluorescence Assay)IF20232026-07-10
06954414735598MAGICL FT3 (CLIA)CLIA3008ACLIA3008A2026-07-10
06954414735635MAGICL FT3 (CLIA)CLIA3008ACLIA3008A2026-07-10
06954414735932MAGICL T3 (CLIA)CLIA3006ACLIA3006A2026-07-10
06954414735956MAGICL T3 (CLIA)CLIA3006ACLIA3006A2026-07-10
06954414735970MAGICL T4 (CLIA)CLIA3007A2026-07-10