FDA.reportPublic FDA data

Estrone Serum

Primary DI
04048474046540
Brand
Estrone Serum
Company
DRG Instruments Gesellschaft mit beschränkter Haftung
Model
CLA-4654
Catalog number
CLA-4654
Device description
For the quantitative determination of Estrone in human saliva by a chemiluminescence immunoassay.
Published
2023-08-26
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
CGFRadioimmunoassay, Estrone

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CGFRadioimmunoassay, EstroneClinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04048474046540PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04048474046540040484740465404048474046540

GMDN Terms#

Term, Definition table
TermDefinition
Centrifuge tube IVDA tube intended to be used in the laboratory to contain a clinical specimen, reagent, or other material associated with in vitro diagnostic testing, for separation by centrifugation. It is designed to be placed in a centrifuge rotor for the procedure; it may also be placed in a rack for short-term storage of its contents. It is typically transparent to facilitate observation of its contents, frequently includes a cap (e.g., screw or press-fit), and may have graduations along the side. This is a single-use device.

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
1 973-564-7555corpoffice@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
04048474040791Estrone ELISADRG Instruments Gesellschaft mit beschränkter HaftungCGF2023-08-31
04048474041743Estrone ELISADRG Instruments Gesellschaft mit beschränkter HaftungCGF2023-08-31
00840239041746Estrone ELISADRG International IncCGF2023-08-25
15099590211547Estrone-sulfate RIAIMMUNOTECH s.r.o.CGF2023-07-06
15099590211615Estrone RIAIMMUNOTECH s.r.o.CGF2023-07-06
B652IB59105Estrone ELISAIBL AmericaCGF2023-06-08
04049016148388Estrone ELISAEUROIMMUN Medizinische Labordiagnostika AGCGF2022-12-08
B261CANE4200DBC Estrone ELISADiagnostics Biochem Canada IncCGF2022-11-10
B261CANE4208PK0DBC Estrone ELISADiagnostics Biochem Canada IncCGF2022-11-10
00404847441741Estrone ELISADRG Instruments Gesellschaft mit beschränkter HaftungCGF2021-06-07
00840239040794Estrone ELISADRG International IncCGF2021-06-07
00840239046543Estrone Serum ELISADRG International IncCGF2021-06-07
B24211ESRHUE010Estrone ELISAAMERICAN LABORATORY PRODUCTS COMPANY, LTD.CGF2020-09-25
05400569000674Estrone-RIA-CTDiasource Immunoassays S.A. SACGF2020-09-16
05400569005167Estrone ELISADiasource Immunoassays S.A. SACGF2020-01-09