FDA.report

Progesterone ELISA

Primary DI
00840239015617
Brand
Progesterone ELISA
Company
DRG International Inc
Model
EIA-1561
Catalog number
EIA-1561
Device description
The DRG Progesterone ELISA is an enzyme immunoassay for the quantitative in vitro diagnostic measurement of Progesterone in serum or plasma (EDTA, lithium heparin or citrate 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
JLSRadioimmunoassay, Progesterone

Product Code Classifications

CodeDeviceSpecialtyClass
JLSRadioimmunoassay, ProgesteroneClinical Chemistry1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00840239015617PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00840239015617008402390156178402390156170840239015617

GMDN Terms

TermDefinition
Insulin-like growth factor I (IGF1) 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 insulin-like growth factor I (IGF1), also referred to as somatomedin C, 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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04048474046632Progesterone (serum) ELISADRG Instruments Gesellschaft mit beschränkter HaftungJLS2024-11-21
07613336218419Elecsys Progesterone IIIRoche Diagnostics GmbHJLS2024-05-30
15099590752682Access Progesterone IIBeckman Coulter, Inc.JLS2024-03-01
15099590752705Access Progesterone II Sample DiluentBeckman Coulter, Inc.JLS2024-03-01
04048474029314Salivary Progesterone ELISA DRG Instruments Gesellschaft mit beschränkter HaftungJLS2023-09-01
04048474053685Progesterone DRG Instruments Gesellschaft mit beschränkter HaftungJLS2023-09-01
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00840239029317Salivary Progesterone ELISA DRG International IncJLS2023-08-26
00840239053688Progesterone DRG International IncJLS2023-08-26
00840239059116Salivary Progesterone HS ELISADRG International IncJLS2023-08-26
00840239046635Progesterone (serum) DRG International IncJLS2023-08-22
00817830023167MP Biomedicals LLCMp Biomedicals, LLCJLS2023-08-02
00817830023174MP Biomedicals LLCMp Biomedicals, LLCJLS2023-08-02
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03770024321609PROGEST-USCISBIO BIOASSAYSJLS2021-12-07
15099590231354ACCESS PROGESTERONE CALIBRATOR S0Beckman Coulter, Inc.JLS2021-09-03
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