FDA.reportPublic FDA data

Progesterone (serum) ELISA

Primary DI
00404847446630
Brand
Progesterone (serum) ELISA
Company
DRG Instruments Gesellschaft mit beschränkter Haftung
Model
CLA-4663
Catalog number
CLA-4663
Device description
The DRG Progesterone Chemiluminescence Immunoassay Kit provides materials for the quantitative determination of Progesterone in serum and plasma.
Published
2021-06-07
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
JLSRADIOIMMUNOASSAY, PROGESTERONE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JLSRadioimmunoassay, ProgesteroneClinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00404847446630PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00404847446630004048474466304048474466300404847446630

GMDN Terms#

Term, Definition table
TermDefinition
Progesterone IVD, kit, chemiluminescent immunoassayA collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of progesterone in a clinical specimen, using a chemiluminescent immunoassay method.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(973)564-7555corp@drg-international.com

Regulatory Flags#

DUNS number
317134468
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04048474041170ANA Detect ELISAEIA-4117EIA-41172023-08-31
04048474027730ANA Screen IgG ELISA EIA-2773EIA-27732023-08-29
04048474035629ANA-8-Screen ELISAEIA-3562EIA-35622019-06-05
04048474035636ANA Combi (ANA-8-Profile) ELISAEIA-3563EIA-35632019-06-10
04048474018646TGF-Beta 1 ELISAEIA-1864EIA-18642024-11-22
04048474059670Measles Virus IgG Avidity ELISAEIA-5967EIA-59672023-09-01
04048474060591Giardia/Cryptosporidium Ag (stool) ELISA EIA-6059EIA-60592023-09-01
04048474027747DNA (ds) IgG ELISAEIA-2774EIA-27742023-08-29
04048474027938Epstein Barr Virus VCA IgG ELISAEIA-2793EIA-27932023-08-29
04048474027945Epstein Barr Virus VCA IgM ELISAEIA-2794EIA-27942023-08-29
04048474027969EBV-EA IgG ELISAEIA-2796EIA-27962023-08-29
04048474028157H. Pylori IgG ELISA EIA-2815EIA-28152023-08-29
04048474033717Gliadin IgG ELISA EIA-3371EIA-33712023-08-29
04048474034448Adenovirus Antigen (stool) ELISA EIA-3444EIA-34442023-08-29
04048474034677Cryptosporidium Antigen (stool) ELISA EIA-3467EIA-34672023-08-29
04048474034738Entamoeba histolytica Ag (stool) ELISA EIA-3473EIA-34732023-08-29
04048474034776Giardia lamblia Antigen (stool) ELISA EIA-3477EIA-34772023-08-29
04048474036022Anti-Lactoferrin ELISAEIA-3602EIA-36022023-08-29
04048474035520hGH ELISAEIA-3552EIA-35522019-06-10
04048474035612Anti TPO Ab ELISAEIA-3561EIA-35612019-06-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00894175000800AccuDiag™ Progesterone ELISADiagnostic Automation, Inc.JLS2026-01-30
14562185399667CL AIA-PACK Progesterone TEST CUPTOSOH CORPORATIONJLS2025-09-01
24562185399664CL AIA-PACK Progesterone TEST CUPTOSOH CORPORATIONJLS2025-09-01
10758750035366VITROSORTHO CLINICAL DIAGNOSTICSJLS2025-05-20
20758750035363VITROSORTHO CLINICAL DIAGNOSTICSJLS2025-05-20
04048474015614Progesterone ELISADRG Instruments Gesellschaft mit beschränkter HaftungJLS2024-11-22
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
04048474059113Salivary Progesterone HS ELISADRG Instruments Gesellschaft mit beschränkter HaftungJLS2023-09-01
00840239029317Salivary Progesterone ELISA DRG International IncJLS2023-08-26
00840239053688Progesterone DRG International IncJLS2023-08-26
00840239059116Salivary Progesterone HS ELISADRG International IncJLS2023-08-26
00840239015617Progesterone ELISADRG International IncJLS2023-08-23
00840239046635Progesterone (serum) DRG International IncJLS2023-08-22
00817830023167MP Biomedicals LLCMp Biomedicals, LLCJLS2023-08-02
00817830023174MP Biomedicals LLCMp Biomedicals, LLCJLS2023-08-02
00817830023181MP Biomedicals LLCMp Biomedicals, LLCJLS2023-08-02
00817830023198MP Biomedicals LLCMp Biomedicals, LLCJLS2023-08-02
00850039602733PantexPantexJLS2023-03-17
00850039602375PantexPantexJLS2023-02-17
B261CANP3050DBC Progesterone ELISADiagnostics Biochem Canada IncJLS2022-11-15
06925912718918iFlash-ProgesteroneShenzhen YHLO Biotech Co., Ltd.JLS2022-10-26
03770024321609PROGEST-USCISBIO BIOASSAYSJLS2021-12-07
15099590231354ACCESS PROGESTERONE CALIBRATOR S0Beckman Coulter, Inc.JLS2021-09-03
15099590231378Access ProgesteroneBeckman Coulter, Inc.JLS2021-09-03
00404847415612Progesterone ELISADRG Instruments Gesellschaft mit beschränkter HaftungJLS2021-06-07