FDA.report

Estradiol (serum)

Primary DI
00840239046642
Brand
Estradiol (serum)
Company
DRG International Inc
Model
CLA-4664
Catalog number
CLA-4664
Device description
The DRG Estradiol CLIA is a Chemiluminescence Immunoassay for the quantitative in vitro diagnostic measurement of Estradiol in serum and plasma.
Published
2023-08-22
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
CHPRadioimmunoassay, Estradiol

Product Code Classifications

CodeDeviceSpecialtyClass
CHPRadioimmunoassay, EstradiolClinical Chemistry1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00840239046642PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00840239046642008402390466428402390466420840239046642

GMDN Terms

TermDefinition
Estradiol (oestradiol) (E2) IVD, kit, chemiluminescent immunoassayA collection of reagents and other associated materials intended to be used for the quantitative measurement of the estrogen (oestrogen) hormone estradiol (oestradiol) in a clinical specimen, using a chemiluminescent immunoassay method.

Storage And Handling

TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods

Method

Contacts

PhoneEmail
9735647555corp@drg-international.com

Regulatory Flags

DUNS number
075150847
Device count
1
DM exempt
false
Premarket exempt
true
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

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