FDA.reportPublic FDA data

TLI IQ®

Primary DI
15420045501171
Brand
TLI IQ®
Company
Hologic, Inc.
Model
TLIIQ QCETTE ASSY
Catalog number
01175
Device description
TLI IQ® QCette®
Published
2014-09-30
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
15420045501171PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1542004550117115420045501171

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 Temperature15 Degrees Celsius30 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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05420045503888SecurMarkSMARK-U-SS1SMARK-U-SS12015-09-04
05420045503895SecurMarkSMARK-U-SS2SMARK-U-SS22015-09-04
05420045503901SecurMarkSMARK-U-SS3SMARK-U-SS32015-09-04
15420045511859Unifi WorkspaceUnifi Workspace V1.02019-08-09
15420045515307Acessa ProVu System710071002023-05-16
15420045515314Acessa ProVu SystemMS-06-0171MS-06-01712023-05-16
15420045515284Acessa ProVu System520052002022-11-08
15420045513983BioZorbF0202F02022021-04-21
15420045513990BioZorbF0203F02032021-04-21
15420045514003BioZorbF0303F03032021-04-21
15420045514010BioZorbF0304F03042021-04-21
15420045514027BioZorbF0221F02212021-04-21
15420045514034BioZorbF0231F02312021-04-21
15420045514041BioZorbF0331F03312021-04-21
15420045514058BioZorbF0404F04042021-04-21
15420045514065BioZorbF0405F04052021-04-21
15420045512634Unifi WorkspaceUnifi Workspace V1.02020-09-21
15420045500020Selenia Dimensions C-View SoftwareC-ViewSW-030522014-09-05
15420045504561ATEC IntroducerAI090920AI0909202016-08-11
15420045504578ATEC IntroducerAI091220AI0912202016-08-11

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
15420045500877TLiIQ SystemHologic, Inc.LKV2014-09-02
15420045500884TLiIQ SystemHologic, Inc.LKV2014-09-02
25420045501154Rapid fFN®Hologic, Inc.LKV2014-08-18
15420045501164Rapid fFN®Hologic, Inc.LKV2014-08-18