FDA.report

Dimension Vista® Flex® reagent cartridge PROG

Primary DI
00842768026478
Brand
Dimension Vista® Flex® reagent cartridge PROG
Company
Siemens Healthcare Diagnostics Inc.
Model
10461743
Catalog number
K6464
Device description
LOCI Progesterone Flex® reagent cartridge, 320 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
false

Related Records

Contact Domains

Product Codes

CodeName
JLSRADIOIMMUNOASSAY, PROGESTERONE

Product Code Classifications

CodeDeviceSpecialtyClass
JLSRadioimmunoassay, ProgesteroneClinical Chemistry1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00842768026478PrimaryGS10
00630414005461Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00842768026478008427680264788427680264780842768026478
00630414005461006304140054616304140054610630414005461

GMDN Terms

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

TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods

Method

Contacts

PhoneEmail
+1(800)441-9250XX@XX.XX
+1(800)441-9250CONTACT@SIEMENS-HEALTHINEERS.COM

Regulatory Flags

DUNS number
005088112
Device count
4
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

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07613336218419Elecsys Progesterone IIIRoche Diagnostics GmbHJLS2024-05-30
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00840239029317Salivary Progesterone ELISA DRG International IncJLS2023-08-26
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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
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03770024321609PROGEST-USCISBIO BIOASSAYSJLS2021-12-07
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