FDA.reportPublic FDA data

Aptima®

Primary DI
15420045512030
Brand
Aptima®
Company
Hologic, Inc.
Model
KIT, BOX 2, ROOM TEMP, ABV, 100T, IVD
Catalog number
ASY-11551
Device description
Aptima® BV assay, 100 test, box 2 of 2 (15°C to 30°C box). The Aptima® BV assay is an in vitro nucleic acid amplification test that utilizes real time transcription-mediated amplification (TMA®) for detection and quantitation of ribosomal RNA from bacteria associated with bacterial vaginosis (BV), including Lactobacillus (L. gasseri, L. crispatus, and L. jensenii), Gardnerella vaginalis, and Atopobium vaginae.
Published
2019-07-02
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
NSUInstrumentation for clinical multiplex test systems
PMNAssayed external control material for microbiology nucleic acid amplification (NAT) assays
PQAVaginitis and bacterial vaginosis nucleic acid detection system

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NSUInstrumentation For Clinical Multiplex Test SystemsClinical Chemistry2
PMNAssayed External Control Material For Microbiology Nucleic Acid Amplification (Nat) AssaysMicrobiology2
PQAVaginitis And Bacterial Vaginosis Nucleic Acid Detection SystemMicrobiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K190452000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K190452000Aptima BV AssayHologic, Inc.2019-05-23PQA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
15420045512030PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1542004551203015420045512030

GMDN Terms#

Term, Definition table
TermDefinition
Multiple vaginitis-associated organism nucleic acid IVD, kit, nucleic acid technique (NAT)A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of nucleic acid from one or multiple organisms associated with vaginitis in a clinical specimen, using a nucleic acid technique (NAT). Organisms intended to be detected may include Candida or other yeast species, Gardnerella vaginalis and/or Trichomonas vaginalis.

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
Expiration date on label
true

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Primary DI, Brand, Model table
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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

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