FDA.reportPublic FDA data

D3

Primary DI
30014613330240
Brand
D3
Company
DIAGNOSTIC HYBRIDS, INC.
Model
01-00050
Catalog number
01-00050
Device description
RSV Antigen Control Slides
Published
2019-04-02
Public version status
Update
Distribution status
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
LJGQUALITY CONTROL SLIDES

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LJGQuality Control SlidesMicrobiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30014613330240PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3001461333024030014613330240

GMDN Terms#

Term, Definition table
TermDefinition
Respiratory syncytial virus (RSV) antigen IVD, kit, fluorescent immunoassayA collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of antigens from respiratory syncytial virus (RSV) in a clinical specimen, using a fluorescent immunoassay method.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(858)552-1100technicalsupport@quidel.com

Regulatory Flags#

DUNS number
117359612
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
30014613330288D3 Ultra01-010000.V201-010000.V22019-03-07
30014613330875D3 Fastpoint01-12350401-1235042019-03-07
00050428101735CVS Health At Home COVID-19 Test Kit204522895862025-08-08
30014613340089Savanna20382R20382R2024-07-19
30014613339304Savanna20382203822024-04-30
30014613340188CVS Health At Home COVID-19 Test Kit204522895862024-11-20
30014613311034LyraM103M1032016-09-15
30014613311157Quidel MolecularM115M1152018-11-16
30014613330752D3 FastpointRespiratory Virus ID Kit01-1200002016-09-15
30014613330769D3 Fastpoint01-120000.B101-120000.B12018-07-22
30014613330776D3 Fastpoint01-120000.B201-120000.B22018-07-22
30014613330813D3 FastpointRSV/MPV ID Kit01-1200022016-09-15
30014613330820D3 Fastpoint01-120002.B101-120002.B12018-07-22
30014613330837D3 Fastpoint01-120002.B201-120002.B22018-07-22
30014613336143SolanaM306M3062018-08-07
30014613338659D301-002007b01-002007b2019-04-23
30014613340119Savanna20445204452024-04-30
30014613340485SavannaM409-1M409-12024-04-30
30014613340492SavannaM409-4M409-42024-04-30
30014613330486D301-01501001-0150102023-07-10

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Primary DI, Brand, Company table
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B502BSB0309CS02-Core HHV-8 Cell Line Microarray Control SlidesBIO SB, INC.LJG2025-03-18
B502BSB0310CS02-Core Adenovirus Cell Line Microarray Control SlidesBIO SB, INC.LJG2025-03-18
B502BSB0333CS02-core Human PIN TMA Control SlidesBIO SB, INC.LJG2025-03-18
B502BSB9000CS0A-1-Antichymotrypsin Control SlidesBIO SB, INC.LJG2025-03-18
B502BSB9001CS0A-1-Antitrypsin Control SlidesBIO SB, INC.LJG2025-03-18
B502BSB9002CS0ACE2 Control SlidesBIO SB, INC.LJG2025-03-18
B502BSB9003CS0ACTH Control SlidesBIO SB, INC.LJG2025-03-18
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B502BSB9005CS0Actin Smooth Muscle Control SlidesBIO SB, INC.LJG2025-03-18
B502BSB9006CS0Adenovirus Control SlidesBIO SB, INC.LJG2025-03-18
B502BSB9007CS0Adipophilin/ADRP Control SlidesBIO SB, INC.LJG2025-03-18
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B502BSB9011CS0Alpha Synuclein Control SlidesBIO SB, INC.LJG2025-03-18
B502BSB9012CS0Alpha-Fetoprotein Control SlidesBIO SB, INC.LJG2025-03-18
B502BSB9013CS0AMACRacemase/P504S Control SlidesBIO SB, INC.LJG2025-03-18
B502BSB9014CS0Amyloid A Control SlidesBIO SB, INC.LJG2025-03-18
B502BSB9015CS0Amyloid Beta Control SlidesBIO SB, INC.LJG2025-03-18
B502BSB9016CS0Androgen Receptor Control SlidesBIO SB, INC.LJG2025-03-18
B502BSB9017CS0Annexin A1 Control SlidesBIO SB, INC.LJG2025-03-18
B502BSB9018CS0Annexin VII Control SlidesBIO SB, INC.LJG2025-03-18
B502BSB9019CS0Arginase-1 Control SlidesBIO SB, INC.LJG2025-03-18
B502BSB9020CS0ARID1A Control SlidesBIO SB, INC.LJG2025-03-18
B502BSB9021CS0ATM Control SlidesBIO SB, INC.LJG2025-03-18
B502BSB9022CS0ATRX Control SlidesBIO SB, INC.LJG2025-03-18
B502BSB9023CS0Aurora B Control SlidesBIO SB, INC.LJG2025-03-18
B502BSB9024CS0B7H3/CD276 Control SlidesBIO SB, INC.LJG2025-03-18