FDA.report

DHEA-S ELISA

Primary DI
00840239015624
Brand
DHEA-S ELISA
Company
DRG International Inc
Model
EIA-1562
Catalog number
EIA-1562
Device description
The DRG DHEA S ELISA is an enzyme immunoassay for the quantitative in vitro diagnostic measurement of DHEA-S in serum and plasma
Published
2023-08-23
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
JKCRadioimmunoassay, Dehydroepiandrosterone (Free And Sulfate)

Product Code Classifications

CodeDeviceSpecialtyClass
JKCRadioimmunoassay, Dehydroepiandrosterone (Free And Sulfate)Clinical Chemistry1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00840239015624PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00840239015624008402390156248402390156240840239015624

GMDN Terms

TermDefinition
Dehydroepiandrosterone sulfate (DHEAS) IVD, kit, chemiluminescent immunoassayA collection of reagents and other associated materials intended to be used for the quantitative measurement of dehydroepiandrosterone sulfate (DHEAS) 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
9735647555corpoffice@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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