FDA.reportPublic FDA data

ACCUPROBE®

Primary DI
15420045506121
Brand
ACCUPROBE®
Company
Hologic, Inc.
Model
KIT,ACCUPROBE,M.INTRACELLULARE
Catalog number
102840
Device description
AccuProbe® Mycobacterium intracellulare.
Published
2016-04-15
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
LQFDNA-REAGENTS, MYCOBACTERIUM SPP.

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LQFDna-Reagents, Mycobacterium Spp.Microbiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
15420045506121PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1542004550612115420045506121

GMDN Terms#

Term, Definition table
TermDefinition
Multiple Mycobacterium species 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 species of Mycobacterium bacteria in a clinical specimen and/or culture isolate, using a nucleic acid technique (NAT).

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
15420045515314Acessa ProVu SystemMS-06-0171MS-06-01712023-05-16
15420045515284Acessa ProVu System520052002022-11-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
15420045506459ACCUPROBE®Hologic, Inc.LQF2016-05-02
15420045506091ACCUPROBEHologic, Inc.LQF2016-04-15
15420045506114ACCUPROBE®Hologic, Inc.LQF2016-04-15
15420045506138ACCUPROBE®Hologic, Inc.LQF2016-04-15
15420045506145ACCUPROBE®Hologic, Inc.LQF2016-04-15
15420045506152ACCUPROBE®Hologic, Inc.LQF2016-04-15
15420045506169ACCUPROBE®Hologic, Inc.LQF2016-04-15