FDA.reportPublic FDA data

T-4 Total ELISA

Primary DI
04048474045680
Brand
T-4 Total ELISA
Company
DRG Instruments Gesellschaft mit beschränkter Haftung
Model
EIA-4568
Catalog number
EIA-4568
Device description
The DRG T4 Total ELISA is an enzyme immunoassay for the quantitative in vitro diagnostic measurement of total Thyroxin (T4) in serum or plasma (EDTA, lithium heparin or citrate plasma).
Published
2023-08-31
Public version status
New
Distribution status
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
CDXRadioimmunoassay, Total Thyroxine

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CDXRadioimmunoassay, Total ThyroxineClinical Chemistry2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04048474045680PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04048474045680040484740456804048474045680

GMDN Terms#

Term, Definition table
TermDefinition
Multiple thyroid marker IVD, kit, enzyme immunoassay (EIA)A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of multiple thyroid markers associated with thyroid disease in a clinical specimen using an enzyme immunoassay (EIA) method. Analytes detected may include, but are not limited to, free triiodothyronine (FT3), free thyroxine (FT4), thyroid stimulating hormone (TSH) and/or thyroid peroxidase (TPO).

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

Regulatory Flags#

DUNS number
317134468
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04048474041170ANA Detect ELISAEIA-4117EIA-41172023-08-31
04048474027730ANA Screen IgG ELISA EIA-2773EIA-27732023-08-29
04048474035629ANA-8-Screen ELISAEIA-3562EIA-35622019-06-05
04048474035636ANA Combi (ANA-8-Profile) ELISAEIA-3563EIA-35632019-06-10
04048474018646TGF-Beta 1 ELISAEIA-1864EIA-18642024-11-22
04048474059670Measles Virus IgG Avidity ELISAEIA-5967EIA-59672023-09-01
04048474060591Giardia/Cryptosporidium Ag (stool) ELISA EIA-6059EIA-60592023-09-01
04048474027747DNA (ds) IgG ELISAEIA-2774EIA-27742023-08-29
04048474027938Epstein Barr Virus VCA IgG ELISAEIA-2793EIA-27932023-08-29
04048474027945Epstein Barr Virus VCA IgM ELISAEIA-2794EIA-27942023-08-29
04048474027969EBV-EA IgG ELISAEIA-2796EIA-27962023-08-29
04048474028157H. Pylori IgG ELISA EIA-2815EIA-28152023-08-29
04048474033717Gliadin IgG ELISA EIA-3371EIA-33712023-08-29
04048474034448Adenovirus Antigen (stool) ELISA EIA-3444EIA-34442023-08-29
04048474034677Cryptosporidium Antigen (stool) ELISA EIA-3467EIA-34672023-08-29
04048474034738Entamoeba histolytica Ag (stool) ELISA EIA-3473EIA-34732023-08-29
04048474034776Giardia lamblia Antigen (stool) ELISA EIA-3477EIA-34772023-08-29
04048474036022Anti-Lactoferrin ELISAEIA-3602EIA-36022023-08-29
04048474035520hGH ELISAEIA-3552EIA-35522019-06-10
04048474035612Anti TPO Ab ELISAEIA-3561EIA-35612019-06-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850054026484QMedix™Diagnostic Automation, Inc.CDX2024-01-31
00840239045591Mycoplasma hominis IgG ELISADRG International IncCDX2023-08-25
00840239045683T-4 Total ELISADRG International IncCDX2023-08-25
06925912718512iFlash-T4Shenzhen YHLO Biotech Co., Ltd.CDX2022-10-26
07613336171660Elecsys T4Roche Diagnostics GmbHCDX2021-08-13
07613336171677Elecsys T4Roche Diagnostics GmbHCDX2021-08-13
00816870021218N-T4 AccuBind ELISA Test System - 96 WellsMONOBIND, INC.CDX2019-02-11
00816870021225N-T4 AccuBind ELISA Test System - 192 WellsMONOBIND, INC.CDX2019-02-11
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00816870021249N-T4 AccuBind ELISA Test System - 960 WellsMONOBIND, INC.CDX2019-02-11
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00816870021690T4 SBS AccuBind ELISA Test System - 96 WellsMONOBIND, INC.CDX2019-02-11
00816870021706T4 SBS AccuBind ELISA Test System - 192 WellsMONOBIND, INC.CDX2019-02-11
00816870023090T4 AccuLite CLIA Test System - 96 WellsMONOBIND, INC.CDX2019-02-11
00816870023106Monobind AccuLite T4 CLIA Kit - 192 WellsMONOBIND, INC.CDX2019-02-11
00816870023113T4 AccuLite CLIA Test System - 480 WellsMONOBIND, INC.CDX2019-02-11
00816870023120T4 AccuLite CLIA Test System - 960 WellsMONOBIND, INC.CDX2019-02-11
00816870023137T4 SBS AccuLite CLIA Test System - 96 WellsMONOBIND, INC.CDX2019-02-11
00816870023144T4 SBS AccuLite CLIA Test System - 192 WellsMONOBIND, INC.CDX2019-02-11
00630414599984Atellica IM T4Siemens Healthcare Diagnostics Inc.CDX2018-02-06
00630414599991Atellica IM T4 DILSiemens Healthcare Diagnostics Inc.CDX2018-02-06
04015630939800Elecsys T4Roche Diagnostics GmbHCDX2017-04-21
00817830022467Total T4 MAb 125I RIA KitMP BIOMEDICALS, LLCCDX2016-10-20
00817830022474Total T4 MAb 125I RIA KitMP BIOMEDICALS, LLCCDX2016-10-20
00817830022481Total T4 MAb 125I RIA KitMP BIOMEDICALS, LLCCDX2016-10-20
00630414125121ADVIA Centaur® T4 DILSiemens Healthcare Diagnostics Inc.CDX2016-09-24