FDA.reportPublic FDA data

RESPDIRECT™

Primary DI
25420045516691
Brand
RESPDIRECT™
Company
Hologic, Inc.
Model
RESPDIRECT COLLECTION KIT, US-KIT, BOX
Catalog number
PRD-07788
Device description
RespDirect™ Collection Kit, 50 count.
Published
2023-08-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
QOFMulti-target respiratory specimen nucleic acid test including SARS-CoV-2 and other microbial agents

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QOFMulti-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial AgentsMicrobiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K222736000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K222736000Panther Fusion SARS-CoV-2/Flu A/B/RSV AssayHologic, Inc.2023-05-16QOF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
25420045516691PrimaryGS10
15420045516694Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2542004551669125420045516691
1542004551669415420045516694

GMDN Terms#

Term, Definition table
TermDefinition
Oral/upper respiratory tract specimen collection kit IVD, clinicalA collection of devices intended exclusively for professional use to assist in the extraction/collection, and preservation and/or transport, of a saliva/oral, nasal, nasopharyngeal, and/or oropharyngeal specimen for in vitro diagnostic investigation. The kit consists of a non-suctioning specimen sampling/collection tool(s) [e.g., swab, brush, spatula, saliva collection mouthpiece/funnel] and a covered specimen receptacle/container(s) with or without an additive/medium [e.g., pre-rinse/irrigation solution, tartrazine colouring agent, transport microbiological medium (e.g., Amies, Stuart, viral transport/inactivation medium)]. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature15 Degrees Celsius30 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
+1(800)442-9892CustomerSupport@hologic.com

Regulatory Flags#

DUNS number
050579217
Device count
50
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
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
15420045500518ProcleixUltrio Plus Negative Calibrators3032602014-08-06

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Primary DI, Brand, Company table
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05061098480025NuLexaLEX DIAGNOSTICS LIMITEDQOF2026-04-24
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20816101027365Simplexa COVID-19 / Flu A/B & RSV Positive Control PackDIASORIN MOLECULAR LLCQOF2026-01-14
04053228039402QIAstat-Dx® Respiratory Panel PlusQIAGEN GmbHQOF2025-09-25
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00810031720019Visby Medical Respiratory Health Visby Medical, Inc.QOF2025-03-19
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