FDA.report

T3-Uptake ELISA

Primary DI
04048474032673
Brand
T3-Uptake ELISA
Company
DRG Instruments Gesellschaft mit beschränkter Haftung
Model
EIA-3267
Catalog number
EIA-3267
Device description
The measurement of the total amount of binding sites available for the Thyroid Hormones in human serum or plasma by a microplate enzyme Immunoassay.
Published
2023-08-29
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
KHQRadioassay, Triiodothyronine Uptake

Product Code Classifications

CodeDeviceSpecialtyClass
KHQRadioassay, Triiodothyronine UptakeClinical Chemistry2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04048474032673PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04048474032673040484740326734048474032673

GMDN Terms

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

TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods

Method

Contacts

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

Regulatory Flags

DUNS number
317134468
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
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 DIBrandModelCatalogPublished
04048474040876GAD65 Ab ELISAEIA-4087EIA-40872024-12-02
04048474012880FSH ELISAEIA-1288EIA-12882024-11-22
04048474012897LH-Serum ELISAEIA-1289EIA-12892024-11-22
04048474012903LH-Urine ELISAEIA-1290EIA-12902024-11-22
04048474012910Prolactin ELISAEIA-1291EIA-12912024-11-22
04048474012934C-Peptide ELISAEIA-1293EIA-12932024-11-22
04048474015591Testosterone ELISAEIA-1559EIA-15592024-11-22
04048474015614Progesterone ELISAEIA-1561EIA-15612024-11-22
04048474015621DHEA-S ELISAEIA-1562EIA-15622024-11-22
04048474016123Free Estriol ELISAEIA-1612EIA-16122024-11-22
04048474018264Sperm Antibody ELISAEIA-1826EIA-18262024-11-22
04048474018646TGF-Beta 1 ELISAEIA-1864EIA-18642024-11-22
04048474023961TGF-Beta 2 ELISAEIA-2396EIA-23962024-11-22
04048474027754RF IgM (Rheumatoid Factor) ELISAEIA-2775EIA-27752024-11-22
04048474046632Progesterone (serum) ELISACLA-4663CLA-46632024-11-21
04048474046649Estradiol (serum) ELISACLA-4664CLA-46642024-11-21
0404847401292717 OH-Progesterone ELISAEIA-1292EIA-12922024-11-18
04048474023855Free Triiodothyronine (fT3) ELISAEIA-2385EIA-23852024-09-23
04048474038019Free T3 ELISAEIA-3801EIA-38012024-09-23
04048474053562T3 freeHYE-5356HYE-53562024-09-23

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