FDA.reportPublic FDA data

INVADER

Primary DI
15420045506718
Brand
INVADER
Company
Hologic, Inc.
Model
INVADER MTHFR 677, 1680 TESTS
Catalog number
95-458
Published
2016-08-29
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
OMMTest 5, 10-methylenetetrahydrofolate reductase mutations, genomic dna pcr

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OMMTest 5, 10-Methylenetetrahydrofolate Reductase Mutations, Genomic Dna PcrHematology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K100496000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K100496000INVADER MTHFR 1298Hologic, Inc.2011-04-25OMM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
15420045506718PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1542004550671815420045506718

GMDN Terms#

Term, Definition table
TermDefinition
Methylenetetrahydrofolate reductase (MTHFR) deficiency IVD, kit, nucleic acid technique (NAT)A collection of reagents and other associated materials intended to be used to evaluate a clinical specimen to diagnose, monitor or predict the genetic disorder methylenetetrahydrofolate reductase (MTHFR) deficiency, an inborn error of folate metabolism associated with mutation in the MTHFR gene, using a nucleic acid technique (NAT).

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
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
00840487101513Hypercoagulation Panel (HC) Nucleic Acid Test CartridgeLUMINEX CORPORATIONOMM2019-12-05
00840487101728Hypercoagulation Panel (HC) Sample BufferLUMINEX CORPORATIONOMM2019-12-05
00857573006027Hypercoagulation Panel (HC) Nucleic Acid Test CartridgeNANOSPHERE, INC.OMM2016-09-23
00857573006348Hypercoagulation Panel (HC) Sample BufferNANOSPHERE, INC.OMM2016-09-23
15420045506725INVADERHologic, Inc.OMM2016-09-08
15420045506671INVADERHologic, Inc.OMM2016-08-29
15420045506688INVADERHologic, Inc.OMM2016-08-29