FDA.reportPublic FDA data

Aptima

Primary DI
15420045500174
Brand
Aptima
Company
Hologic, Inc.
Model
HIV-1 Qual
Catalog number
302178
Device description
PAS to Procleix HIV/HCV. Product Code not required for IVD (BL registration numbers)
Published
2014-08-06
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Contact Domains#

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
15420045500174PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1542004550017415420045500174

GMDN Terms#

Term, Definition table
TermDefinition
HIV1 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 human immunodeficiency virus 1 (HIV1) nucleic acid in a clinical specimen, using a nucleic acid technique (NAT).

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature-35 Degrees Celsius-15 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
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
15420045518131Selenia® Dimensions®ASY-10775-2DASY-10775-2D2026-03-12
15420045518148Selenia® Dimensions®ASY-10775-3DASY-10775-3D2026-03-12
15420045518155Selenia® Dimensions®ASY-10775-2D-UPSASY-10775-2D-UPS2026-03-12
15420045518162Selenia® Dimensions®ASY-10775-3D-UPSASY-10775-3D-UPS2026-03-12
15420045518179Selenia® Dimensions®ASY-10775-2D-CNASY-10775-2D-CN2026-03-12
15420045518186Selenia® Dimensions®ASY-08483-2DASY-08483-2D2026-03-12
15420045518193Selenia® Dimensions®ASY-10775-3D-CNASY-10775-3D-CN2026-03-12
15420045518216Selenia® Dimensions®ASY-08483-3DASY-08483-3D2026-03-12
15420045518223Selenia® Dimensions®ASY-08483-3D-CNASY-08483-3D-CN2026-03-12
15420045518230Selenia® Dimensions®ASY-08483-2D-CNASY-08483-2D-CN2026-03-12
15420045518247Affirm Prone Biopsy SystemPBX-SYS-AFFIRM-3D-CNPBX-SYS-AFFIRM-3D-CN2026-03-12
15420045518261Affirm Prone Biopsy SystemPBX-SYS-AFFIRM-2D-CNPBX-SYS-AFFIRM-2D-CN2026-03-12
15420045518278Affirm Prone Biopsy SystemASY-06886-CNASY-06886-CN2026-03-12
15420045518285Affirm Prone Biopsy SystemASY-09175-CNASY-09175-CN2026-03-12
15420045518292Affirm Prone Biopsy SystemASY-08832-CNASY-08832-CN2026-03-12
15420045516236EnvisionASY-14621ASY-146212025-11-13
15420045516243EnvisionASY-14622ASY-146222025-11-13
15420045516250EnvisionASY-14623ASY-146232025-11-13
15420045516267EnvisionASY-14624ASY-146242025-11-13
15420045516274EnvisionASY-14625ASY-146252025-11-13