FDA.reportPublic FDA data

Rapid fFN®

Primary DI
15420045501164
Brand
Rapid fFN®
Company
Hologic, Inc.
Model
KIT, RAPID FFN CONTROL TLIIQ SYSTEM, USA
Catalog number
01166
Device description
Rapid fFN® Control Kit (Rapid fFN® for the TLI IQ® System).
Published
2014-08-18
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LKVENZYME IMMUNOASSAY, FETAL FIBRONECTIN

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LKVEnzyme Immunoassay, Fetal FibronectinUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P920048001
P920048002
P920048003
P920048005
P920048008
P920048009
P920048011
P920048013
P920048019
P920048024

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P920048001FETAL FIBRONECTIN ENZYME IMMUNOASSAY KIT (EIK)Hologic, Inc.1995-09-21LKV
P920048002FETAL FIBRONECTIN ENZYME IMMUNOASSAY KIT (EIK)Hologic, Inc.1995-09-21LKV
P920048003FETAL FIBRONECTIN ENZYME IMMUNOASSAY KIT (EIK)Hologic, Inc.1995-09-21LKV
P920048005FETAL FIBRONECTIN ENZYME IMMUNOASSAY KIT (EIK)Hologic, Inc.1995-09-21LKV
P920048008FETAL FIBRONECTIN ENZYME IMMUNOASSAY KIT (EIK)Hologic, Inc.1995-09-21LKV
P920048009FETAL FIBRONECTIN ENZYME IMMUNOASSAY KIT (EIK)Hologic, Inc.1995-09-21LKV
P920048011FETAL FIBRONECTIN ENZYME IMMUNOASSAY KIT (EIK)Hologic, Inc.1995-09-21LKV
P920048013FETAL FIBRONECTIN ENZYME IMMUNOASSAY KIT (EIK)Hologic, Inc.1995-09-21LKV
P920048019FETAL FIBRONECTIN ENZYME IMMUNOASSAY KIT (EIK)Hologic, Inc.1995-09-21LKV
P920048024FETAL FIBRONECTIN ENZYME IMMUNOASSAY KIT (EIK)Hologic, Inc.1995-09-21LKV

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
15420045501164PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1542004550116415420045501164

GMDN Terms#

Term, Definition table
TermDefinition
Fibronectin IVD, kit, enzyme immunohistochemistryA collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of fibronectin in a clinical specimen, using an enzyme immunohistochemistry 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(800)442-9892CustomerSupport@hologic.com

Regulatory Flags#

DUNS number
050579217
Device count
1
DM exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
25420045516691RESPDIRECT™RESPDIRECT COLLECTION KIT, US-KIT, BOXPRD-077882023-08-14
00850346007030CoolSeal™ TrinityCSL-TR105-30CSL-TR105-302020-10-13
00850346007047CoolSeal™ TrinityCSL-TR105-37CSL-TR105-372020-10-13
00850346007061CoolSeal™ TrinityCSL-TR105-44CSL-TR105-442020-10-13
00850346007092CoolSeal™ RevealCSL-RV105-10CSL-RV105-102021-05-19
00850346007085CoolSeal™ MiniCSL-MN103-20CSL-MN103-202020-10-13
15420045500372ProcleixUltrio Plus 1K3025732014-08-06
15420045500389ProcleixUltrio Plus 1K3025732014-08-06
15420045500396ProcleixUltrio Plus 1K3025732014-08-06
15420045500402ProcleixUltrio Plus 1K3025732014-08-06
15420045500419ProcleixUltrio Plus 5K3025742014-08-06
15420045500426ProcleixUltrio Plus 5K3025742014-08-06
15420045500433ProcleixUltrio Plus 5K3025742014-08-06
15420045500440ProcleixUltrio Plus 5K3025742014-08-06
15420045500457ProcleixUltrio Plus 5K3025742014-08-06
15420045500464ProcleixUltrio Plus, HIV-1 D-Probes3025712014-08-06
15420045500471ProcleixUltrio Plus HBV D-Probes3025762014-08-06
15420045500488ProcleixUltrio Plus HCV D-Probes3025772014-08-06
15420045500495ProcleixUltrio Plus TIGRIS Controls3025722014-08-06
15420045500501ProcleixUltrio Plus Calibrators3025752014-08-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
25420045500874TLiIQ SystemHologic, Inc.LKV2024-08-07
15420045505346FETAL FIBRONECTIN ENZYME IMMUNOASSAYHologic, Inc.LKV2017-02-08
15420045501171TLI IQ®Hologic, Inc.LKV2014-09-30
15420045500877TLiIQ SystemHologic, Inc.LKV2014-09-02
15420045500884TLiIQ SystemHologic, Inc.LKV2014-09-02
25420045501154Rapid fFN®Hologic, Inc.LKV2014-08-18