FDA.reportPublic FDA data

THIRD WAVE

Primary DI
15420045506640
Brand
THIRD WAVE
Company
Hologic, Inc.
Model
UNIVERSAL GENERAL PURPOSE REAGENTS
Catalog number
97-019
Published
2016-09-12
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
JCCPH BUFFER

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JCCPh BufferPathology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
15420045506640PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1542004550664015420045506640

GMDN Terms#

Term, Definition table
TermDefinition
Nucleic acid technique (NAT) chemiluminescent signal generation kit IVDA collection of reagents and other associated materials intended to be used to generate a chemiluminescent signal when performing an assay using a nucleic acid technique (NAT) on a clinical specimen. The kit is typically used in conjunction with luminescent-labelled nucleic acid oligonucleotide probes of known sequences and may also include reference material to optimise and verify performance of the luminometer instrument.

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
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
25420045516691RESPDIRECT™RESPDIRECT COLLECTION KIT, US-KIT, BOXPRD-077882023-08-14
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
15420045500372ProcleixUltrio Plus 1K3025732014-08-06
15420045500389ProcleixUltrio Plus 1K3025732014-08-06
15420045500396ProcleixUltrio Plus 1K3025732014-08-06
15420045500402ProcleixUltrio Plus 1K3025732014-08-06
15420045500419ProcleixUltrio Plus 5K3025742014-08-06
15420045500426ProcleixUltrio Plus 5K3025742014-08-06
15420045500433ProcleixUltrio Plus 5K3025742014-08-06
15420045500440ProcleixUltrio Plus 5K3025742014-08-06
15420045500457ProcleixUltrio Plus 5K3025742014-08-06
15420045500464ProcleixUltrio Plus, HIV-1 D-Probes3025712014-08-06
15420045500471ProcleixUltrio Plus HBV D-Probes3025762014-08-06
15420045500488ProcleixUltrio Plus HCV D-Probes3025772014-08-06
15420045500495ProcleixUltrio Plus TIGRIS Controls3025722014-08-06
15420045500501ProcleixUltrio Plus Calibrators3025752014-08-06

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04015630971008Antibody DiluentVentana Medical Systems, Inc.JCC2025-12-15
04015630972432ULTRA Cell Conditioning Solution (ULTRA CC1)Ventana Medical Systems, Inc.JCC2025-12-15
04015630985012ISH Probe DiluentVentana Medical Systems, Inc.JCC2025-12-15
00810170553585IHCSlmp, LLCJCC2025-03-31
00810170553592IHCSlmp, LLCJCC2025-03-31
08435256719499TBS Tween 20 Buffer 10X q.s. 10LVITRO SAJCC2025-02-20
08435804515078TBS Tween 20 Buffer 10XVITRO SAJCC2025-02-20
00348783012699BufferProPREMIER DENTAL PRODUCTS COMPANYJCC2024-12-18
00860011780540Chemical Service Labs, LLCProtean Resources, LLC.JCC2024-03-18
00860011780557Chemical Service Labs, LLCProtean Resources, LLC.JCC2024-03-18
00860011780564Chemical Service Labs, LLCProtean Resources, LLC.JCC2024-03-18
00860011780595Chemical Service Labs, LLCProtean Resources, LLC.JCC2024-03-18
07540207107803EasySep™ BufferStemcell Technologies Canada IncJCC2024-02-08
00380740136994AlinityAbbott Ireland DiagnosticsJCC2023-11-16
00860001977349OnsetOnpharma CompanyJCC2023-06-01
00810047421047N/AScientific Device Laboratory, Inc.JCC2023-01-31
00810047421054N/AScientific Device Laboratory, Inc.JCC2023-01-31
00847627014528PBS Plus 10XBIOCARE MEDICAL LLCJCC2022-12-07
00847627014559Immunocare PBS 10XBIOCARE MEDICAL LLCJCC2022-12-07
00847627014610TBSplus 10XBIOCARE MEDICAL LLCJCC2022-12-07
00847627014627Automation Tween 20, 20XBIOCARE MEDICAL LLCJCC2022-12-07
00847627014634Immunocare TBS Wash Buffer 10XBIOCARE MEDICAL LLCJCC2022-12-07
0084762701466520% Tween 20BIOCARE MEDICAL LLCJCC2022-12-07
0084762701467220% Tween 20BIOCARE MEDICAL LLCJCC2022-12-07
0084762701468920% Tween 20BIOCARE MEDICAL LLCJCC2022-12-07
00847627014641TBS Auto Wash Buffer 20XBIOCARE MEDICAL LLCJCC2022-09-23
00847627014658TBS Auto Wash Buffer 40XBIOCARE MEDICAL LLCJCC2022-09-23
00816085023311Alpha-Tec SystemsAlpha-TEC Systems, Inc.JCC2022-08-10
00816085023328Alpha-Tec SystemsAlpha-TEC Systems, Inc.JCC2022-08-10
00816085020259Alpha-Tec SystemsAlpha-TEC Systems, Inc.JCC2022-08-10