FDA.report

PRIMA

Primary DI
15420045504691
Brand
PRIMA
Company
Hologic, Inc.
Model
PRIMA
Published
2016-04-06
Public version status
Update
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
LLZSystem, image processing, radiological

Product Code Classifications

CodeDeviceSpecialtyClass
LLZSystem, Image Processing, RadiologicalRadiology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
15420045504691PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
1542004550469115420045504691

GMDN Terms

TermDefinition
Laboratory instrument/analyser application software IVDA software program intended to be used with an in vitro diagnostic instrument/analyser (e.g., microscope slide digital imaging scanner, immunoassay analyser), or a data management device connected to the IVD instrument/analyser, to facilitate user-controlled device function and/or data processing, display, or communication (e.g., image conversion, incubation control).

Sterilization Methods

Method

Contacts

PhoneEmail
+1(800)442-9892CustomerSupport@hologic.com

Regulatory Flags

DUNS number
139534114
Device count
1
DM exempt
true
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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15420045518278Affirm Prone Biopsy SystemASY-06886-CNASY-06886-CN2026-03-12
15420045518285Affirm Prone Biopsy SystemASY-09175-CNASY-09175-CN2026-03-12
15420045518292Affirm Prone Biopsy SystemASY-08832-CNASY-08832-CN2026-03-12
15420045516236EnvisionASY-14621ASY-146212025-11-13
15420045516243EnvisionASY-14622ASY-146222025-11-13
15420045516250EnvisionASY-14623ASY-146232025-11-13
15420045516267EnvisionASY-14624ASY-146242025-11-13
15420045516274EnvisionASY-14625ASY-146252025-11-13

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