Atellica IM PRGE

Primary DI
00630414293714
Brand
Atellica IM PRGE
Company
Siemens Healthcare Diagnostics Inc.
Model
11206257
Catalog number
11206257
Device description
Progesterone (PRGE) - Atellica IM - RGT 450T
Published
2020-05-31
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
JLSRADIOIMMUNOASSAY, PROGESTERONE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JLSRadioimmunoassay, ProgesteroneClinical Chemistry1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K932955000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K932955000CIBA CORNING ACS PROGESTERONE IMMUNOASSAYCiba Corning Diagnostics Corp.1993-08-02JLS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00630414293714PrimaryGS10
00630414294216Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00630414293714006304142937146304142937140630414293714
00630414294216006304142942166304142942160630414294216

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
Special Storage Condition, Specify00Store upright, Protect from light
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
+1(877)229-3711CONTACT@SIEMENS-HEALTHINEERS.COM

Regulatory Flags#

DUNS number
064608573
Device count
5
Lot or batch
true
Expiration date on label
true

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Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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24562185399664CL AIA-PACK Progesterone TEST CUPTOSOH CORPORATIONJLS2025-09-01
10758750035366VITROSORTHO CLINICAL DIAGNOSTICSJLS2025-05-20
20758750035363VITROSORTHO CLINICAL DIAGNOSTICSJLS2025-05-20
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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
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00840239053688Progesterone DRG International IncJLS2023-08-26
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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
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15099590231354ACCESS PROGESTERONE CALIBRATOR S0Beckman Coulter, Inc.JLS2021-09-03
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