FDA.report

LH ELISA

Primary DI
00840239041036
Brand
LH ELISA
Company
DRG International Inc
Model
EIA-4103
Catalog number
EIA-4103
Device description
The Quantitative Determination of Luteinizing Hormone Concentration in Human Serum by a Microplate Enzyme Immunoassay, Colorimetric.
Published
2021-06-07
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
CEPRADIOIMMUNOASSAY, LUTEINIZING HORMONE

Product Code Classifications

CodeDeviceSpecialtyClass
CEPRadioimmunoassay, Luteinizing HormoneClinical Chemistry1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00840239041036PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00840239041036008402390410368402390410360840239041036

GMDN Terms

TermDefinition
Luteinizing hormone (LH) 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 luteinizing hormone (LH) in a clinical specimen, using an enzyme immunoassay (EIA) method.

Storage And Handling

TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods

Method

Contacts

PhoneEmail
+1(973)564-7555corp@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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