FDA.reportPublic FDA data

D3

Primary DI
30014613338659
Brand
D3
Company
DIAGNOSTIC HYBRIDS, INC.
Model
01-002007b
Catalog number
01-002007b
Device description
Mounting Fluid (pH 8.0-8.4)
Published
2019-04-23
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
LEBMOUNTING MEDIA

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LEBMounting MediaPathology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30014613338659PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3001461333865930014613338659

GMDN Terms#

Term, Definition table
TermDefinition
Microscopy mounting medium IVDA substance intended to be used to create a seal between a microscope slide, clinical specimen and/or coverslip to preserve the specimen and enhance image quality during microscopic examination.

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
30014613330240D301-0005001-000502019-04-02
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
30014613340119Savanna20445204452024-04-30
30014613340485SavannaM409-1M409-12024-04-30
30014613340492SavannaM409-4M409-42024-04-30
30014613330486D301-01501001-0150102023-07-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04049016151982Mounting medium (IIFT)EUROIMMUN Medizinische Labordiagnostika AGLEB2025-07-03
04049016152002Mounting medium (IIFT)EUROIMMUN Medizinische Labordiagnostika AGLEB2025-07-03
00613647028612FisherbrandFISHER SCIENTIFIC COMPANY L.L.C.LEB2025-04-30
00613647028650FisherbrandFISHER SCIENTIFIC COMPANY L.L.C.LEB2025-04-30
20613647028616FisherbrandFISHER SCIENTIFIC COMPANY L.L.C.LEB2025-04-30
20613647028654FisherbrandFISHER SCIENTIFIC COMPANY L.L.C.LEB2025-04-30
00860012688937ClaraMount™ Coverslip mounting mediumClarapath, Inc.LEB2024-08-23
00673693073189EprediaRICHARD-ALLAN SCIENTIFIC COMPANYLEB2024-07-30
00673693088947EprediaRICHARD-ALLAN SCIENTIFIC COMPANYLEB2024-07-30
00673693088954EprediaRICHARD-ALLAN SCIENTIFIC COMPANYLEB2024-07-30
00673693088961EprediaRICHARD-ALLAN SCIENTIFIC COMPANYLEB2024-07-30
00673693088978EprediaRICHARD-ALLAN SCIENTIFIC COMPANYLEB2024-07-30
00673693169745EprediaRICHARD-ALLAN SCIENTIFIC COMPANYLEB2024-07-30
00673693170383EprediaRICHARD-ALLAN SCIENTIFIC COMPANYLEB2024-07-30
00673693218627EprediaRICHARD-ALLAN SCIENTIFIC COMPANYLEB2024-07-30
00673693219372EprediaRICHARD-ALLAN SCIENTIFIC COMPANYLEB2024-07-30
00673693219389EprediaRICHARD-ALLAN SCIENTIFIC COMPANYLEB2024-07-30
00673693219396EprediaRICHARD-ALLAN SCIENTIFIC COMPANYLEB2024-07-30
00673693219402EprediaRICHARD-ALLAN SCIENTIFIC COMPANYLEB2024-07-30
00673693228701EprediaRICHARD-ALLAN SCIENTIFIC COMPANYLEB2024-07-30
00673693235921EprediaRICHARD-ALLAN SCIENTIFIC COMPANYLEB2024-07-30
00673693235938EprediaRICHARD-ALLAN SCIENTIFIC COMPANYLEB2024-07-30
00673693235945EprediaRICHARD-ALLAN SCIENTIFIC COMPANYLEB2024-07-30
00673693236058EprediaRICHARD-ALLAN SCIENTIFIC COMPANYLEB2024-07-30
00673693236065EprediaRICHARD-ALLAN SCIENTIFIC COMPANYLEB2024-07-30
00673693236072EprediaRICHARD-ALLAN SCIENTIFIC COMPANYLEB2024-07-30
00673693237482EprediaRICHARD-ALLAN SCIENTIFIC COMPANYLEB2024-07-30
00673693237499EprediaRICHARD-ALLAN SCIENTIFIC COMPANYLEB2024-07-30
00673693270427EprediaRICHARD-ALLAN SCIENTIFIC COMPANYLEB2024-07-30
00673693275194EprediaRICHARD-ALLAN SCIENTIFIC COMPANYLEB2024-07-30