FETAL FIBRONECTIN ENZYME IMMUNOASSAY 00480

GUDID 15420045505346

Hologic, Inc.

Fibronectin IVD, kit, enzyme immunohistochemistry
Primary Device ID15420045505346
NIH Device Record Key6bcc7eac-d699-42b0-9174-553fc6d36645
Commercial Distribution StatusIn Commercial Distribution
Brand NameFETAL FIBRONECTIN ENZYME IMMUNOASSAY
Version Model Number00480
Catalog Number00480
Company DUNS024741117
Company NameHologic, Inc.
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS115420045505346 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LKVENZYME IMMUNOASSAY, FETAL FIBRONECTIN

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2017-02-08

Devices Manufactured by Hologic, Inc.

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15420045517882 - Selenia® Dimensions®2025-07-25 The Selenia® Dimensions® digital mammography system generates digital mammographic images that can be used for screening and
15420045517899 - Selenia® Dimensions®2025-07-25 The Selenia® Dimensions® digital mammography system generates digital mammographic images that can be used for screening and
15420045517905 - Selenia® Dimensions®2025-07-25 The Selenia® Dimensions® digital mammography system is a mammographic system used for capturing digital x-ray images of the b
15420045517912 - Selenia® Dimensions®2025-07-25 The Selenia® Dimensions® digital mammography system is a mammographic system used for capturing digital x-ray images of the b
15420045517929 - Selenia® Dimensions®2025-07-25 The Selenia® Dimensions® digital mammography system is a mammographic system used for capturing digital x-ray images of the b
15420045517936 - Selenia® Dimensions®2025-07-25 The Selenia® Dimensions® digital mammography system is a mammographic system used for capturing digital x-ray images of the b

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