FDA.reportPublic FDA data

INVADER

Primary DI
15420045506688
Brand
INVADER
Company
Hologic, Inc.
Model
INVADER MTHFR 1298, 144 TESTS
Catalog number
95-455
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
K100987000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K100987000INVADER MTHFR 677Hologic, Inc.2011-05-13OMM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
15420045506688PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1542004550668815420045506688

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
15420045518452DIGITAL DIAGNOSTICS SYSTEMDIGITAL CYTOLOGY IMAGERRM-ASY-185882026-10-19
15420045518933DIGITAL DIAGNOSTICS SYSTEMDIGITAL CYTOLOGY IMAGERRM-ASY-185892026-10-19
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
00850346007023CoolSeal™ GeneratorCSL-200-50CSL-200-502020-10-13
15420045515796EnvisionEnvision System Software LicenseCMP-019182026-10-09
15420045515802EnvisionEnvision Tomosynthesis LicenseCMP-029192026-10-09
15420045515864EnvisionEnvision Tomo Synthesized 2D LicenseCMP-019212026-10-09
15420045515871EnvisionEnvision 3DQorum LicenseCMP-019222026-10-09
15420045515895EnvisionEnvision SmartCurve Paddle LicenseCMP-019242026-10-09
15420045517462EnvisionENV-SYS-STDENV-SYS-STD2026-10-09
15420045517479EnvisionENV-SYS-STD-NSENV-SYS-STD-NS2026-10-09
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

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
15420045506718INVADERHologic, Inc.OMM2016-08-29