FDA.reportPublic FDA data

Epredia

Primary DI
00673693220200
Brand
Epredia
Company
RICHARD-ALLAN SCIENTIFIC COMPANY
Model
Uni Cap, Blue
Catalog number
200225
Device description
The UniSystem tubes are disposable, polystyrene tubes graduated to 12 mL, with unique patented tips designed to retain a standardized 0.4 mL volume of sediment or liquid when decanted. Up to 10 tubes can be simultaneously decanted by using the UniSystem Rack or tubes can be individually decanted by hand.
Published
2024-07-31
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
IFBCytocentrifuge

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IFBCytocentrifugePathology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00673693220200PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00673693220200006736932202006736932202000673693220200

GMDN Terms#

Term, Definition table
TermDefinition
Urine specimen collection kit IVDA collection of noninvasive devices intended to be used for the collection, preservation, and transport of a urine specimen for culture, analysis, and/or other investigation. It typically consists of a primary urine collection receptacle (e.g., cup, conical tube, vessel), a urine preservation/transport tube [typically evacuated, with or without additives], and a transfer device for facilitating the aseptic transfer of a urine sample between receptacles; supportive devices for urine collection (e.g., wet wipes, absorbent pads, Foley catheter connector) and/or analysis [e.g., microscope slides, tube rack] may also be included in the kit. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
929504710
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00673693181723EprediaPen-Fix™61052024-11-19
00673693063494EprediaMicrotome Knife, 12 CM, C22220042024-10-29
00673693063500EprediaMicrotome Knife, 16 CM, C1520202024-10-29
00673693063753EprediaMicrotome Knife, 30CM, C1520502024-10-29
00673693063760EprediaMicrotome Knife, 12 CM, D1520602024-10-29
00673693063777EprediaMicrotome Knife, 16 CM, D1520702024-10-29
00673693063784EprediaMicrotome Knife, 22 CM, D1520802024-10-29
00673693063791EprediaMicrotome Knife, 25 CM, D1520902024-10-29
00673693063807EprediaMicrotome Knife, 30 CM, D1521002024-10-29
00673693063814EprediaTungsten Carbide Knife, 16 CM1521202024-10-29
00673693064200EprediaAdamas Blades for Disposable Magnetic Blade Carrie1600102024-10-29
00673693064231EprediaAdamas Blades for Disposable Magnetic Blade Carrie1600402024-10-29
00673693226707EprediaTungsten Carbide D-Profile Microtome Knives56010062024-10-29
00673693263177EprediaMicrotome Knife D-Profile 240 mm22220062024-10-29
00673693568074EprediaHistoPlast IM8331K2024-10-29
00673693220514EprediaMicrotome Knife C-Profile 240 mm22220052024-10-28
00673693232913EprediaStainless-Steel Microtome Knives 12.5 cm76192024-10-28
00673693233149EprediaStandard Microtome Knife 125 mm77022024-10-28
00673693233187EprediaStandard Microtome Knife 250 mm77042024-10-28
00673693233200EprediaStainless-Steel Microtome Knives 18.5 cm77192024-10-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00673693226967EprediaRICHARD-ALLAN SCIENTIFIC COMPANYIFB2024-10-21
00673693226943EprediaRICHARD-ALLAN SCIENTIFIC COMPANYIFB2024-10-18
00673693241731EprediaRICHARD-ALLAN SCIENTIFIC COMPANYIFB2024-10-18
00673693220118EprediaRICHARD-ALLAN SCIENTIFIC COMPANYIFB2024-07-31
00673693220163EprediaRICHARD-ALLAN SCIENTIFIC COMPANYIFB2024-07-31
00673693220101EprediaRICHARD-ALLAN SCIENTIFIC COMPANYIFB2024-07-30
00673693229913EprediaRICHARD-ALLAN SCIENTIFIC COMPANYIFB2024-07-30
00673693229920EprediaRICHARD-ALLAN SCIENTIFIC COMPANYIFB2024-07-30
00673693217880EprediaRICHARD-ALLAN SCIENTIFIC COMPANYIFB2024-07-25
00673693217897EprediaRICHARD-ALLAN SCIENTIFIC COMPANYIFB2024-07-25
00673693222174EprediaRICHARD-ALLAN SCIENTIFIC COMPANYIFB2024-07-25
00673693227025EprediaRICHARD-ALLAN SCIENTIFIC COMPANYIFB2024-07-25
00673693227032EprediaRICHARD-ALLAN SCIENTIFIC COMPANYIFB2024-07-25
00673693227049EprediaRICHARD-ALLAN SCIENTIFIC COMPANYIFB2024-07-25
00673693227056EprediaRICHARD-ALLAN SCIENTIFIC COMPANYIFB2024-07-25
00673693227063EprediaRICHARD-ALLAN SCIENTIFIC COMPANYIFB2024-07-25
05051663517928EprediaSHANDON DIAGNOSTICS LIMITEDIFB2024-02-16
05051663518345EprediaSHANDON DIAGNOSTICS LIMITEDIFB2024-02-16
05051663625265EprediaSHANDON DIAGNOSTICS LIMITEDIFB2024-02-16
05051663625272EprediaSHANDON DIAGNOSTICS LIMITEDIFB2024-02-16
05051663625289EprediaSHANDON DIAGNOSTICS LIMITEDIFB2024-02-16
05051663625302EprediaSHANDON DIAGNOSTICS LIMITEDIFB2024-02-16
05051663625319EprediaSHANDON DIAGNOSTICS LIMITEDIFB2024-02-16
05051663625326EprediaSHANDON DIAGNOSTICS LIMITEDIFB2024-02-16
05051663625340EprediaSHANDON DIAGNOSTICS LIMITEDIFB2024-02-16
07898027907630CELLPRESERV KOLPLASTKolplast C IIFB2023-11-29
03661540302640Cytopro Single Sample Chamber Caps, pack of 48ELITECHGROUP INC.IFB2023-08-14
03661540302664Cytopro Cytopad, slow, tan, package of 100ELITECHGROUP INC.IFB2023-08-14
03661540302671Sample Chambers w/ fast, white Cytopads, caps, pk48ELITECHGROUP INC.IFB2023-08-14
03661540302688Sample Chambers w/Slow, Tan Cytopads, Caps, 48pk.ELITECHGROUP INC.IFB2023-08-14