FDA.reportPublic FDA data

IMMULITE®/IMMULITE® 1000 Systems PRG Progesterone

Primary DI
00630414985732
Brand
IMMULITE®/IMMULITE® 1000 Systems PRG Progesterone
Company
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
Model
10381128
Catalog number
LKPW1
Device description
Progesterone - IMMULITE - RGT - 100 tests
Published
2020-09-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
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
00630414985732PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00630414985732006304149857326304149857320630414985732

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(877)229-3711XX@XX.XX
+1(877)229-3711CONTACT@SIEMENS-HEALTHINEERS.COM

Regulatory Flags#

DUNS number
296822794
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00630414245317Atellica IM Anti-Thyroglobulin II (aTgII)11201759112017592026-02-04
00630414245324Atellica IM Anti-Thyroglobulin II (aTgII)11201761112017612026-02-04
00630414245331Atellica IM aTgII Quality Control (aTgII QC)11201752112017522026-02-04
00630414245348Atellica IM aTgII Master Curve Material (aTgII MCM)11201751112017512026-02-04
00630414245355ADVIA Centaur Anti-Thyroglobulin II (aTgII)11201758112017582026-02-04
00630414245362ADVIA Centaur Anti-Thyroglobulin II (aTgII)11201760112017602026-02-04
00630414245379ADVIA Centaur aTgII Quality Control (aTgII QC)11202552112025522026-02-04
00630414245386ADVIA Centaur aTgII Master Curve Material (aTgII MCM)11200352112003522026-02-04
00630414608754Atellica IM aTPOII11206076112060762026-01-26
00630414608761Atellica IM aTPOII11206077112060772026-01-26
00630414608891Atellica IM aTPOII QC11206984112069842026-01-26
00630414609492Atellica IM aTPOII Diluent11207637112076372026-01-26
00630414608570ADVIA Centaur aTPOII11206075112060752025-11-21
00630414608587ADVIA Centaur aTPOII QC11206985112069852025-11-21
00630414608747ADVIA Centaur aTPOII11206074112060742025-11-21
00630414609409ADVIA Centaur aTPOII Diluent11207635112076352025-11-21
00630414238401Atellica IM Thyroglobulin (Tg)11200449112004492025-09-22
00630414238418Atellica IM Tg11200450112004502025-09-22
00630414238425Atellica IM Tg11200534112005342025-09-22
00630414637877Atellica IM HBcT211643118116431182024-04-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00894175000800AccuDiag™ Progesterone ELISADiagnostic Automation, Inc.JLS2026-01-30
24562185399664CL AIA-PACK Progesterone TEST CUPTOSOH CORPORATIONJLS2025-09-01
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
00404847429312Salivary Progesterone ELISADRG Instruments Gesellschaft mit beschränkter HaftungJLS2021-06-07
00404847441574SALI-TUBES 500DRG Instruments Gesellschaft mit beschränkter HaftungJLS2021-06-07