FDA.report

Proinsulin ELISA

Primary DI
00840239015600
Brand
Proinsulin ELISA
Company
DRG International Inc
Model
EIA-1560
Catalog number
EIA-1560
Device description
The DRG Proinsulin ELISA is an enzyme immunoassay for the quantitative in vitro diagnostic measurement of Proinsulin (intact) 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
JKDRadioimmunoassay, C-Peptides Of Proinsulin

Product Code Classifications

CodeDeviceSpecialtyClass
JKDRadioimmunoassay, C-Peptides Of ProinsulinClinical Chemistry1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00840239015600PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00840239015600008402390156008402390156000840239015600

GMDN Terms

TermDefinition
Proinsulin IVD, kit, enzyme immunoassay (EIA)A collection of reagents and other associated materials intended to be used for the quantitative measurement of proinsulin 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
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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00840239029317Salivary Progesterone ELISA SLV-2931SLV-29312023-08-26
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00840239035837Rheumatoid Factor Screen ELISAEIA-3583EIA-35832023-08-25
00840239035844RF IgG (Rheumatoid Factor) ELISAEIA-3584EIA-35842023-08-25
00840239035851Rheumatoid Factor IgM ELISAEIA-3585EIA-35852023-08-25
00840239035868Rheumatoid Factor IgA ELISAEIA-3586EIA-35862023-08-25
00840239035875Anti-Cardiolipin IgG/IgM ELISAEIA-3587EIA-35872023-08-25

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