FDA.reportPublic FDA data

CELL-DYN

Primary DI
00380740001124
Brand
CELL-DYN
Company
ABBOTT LABORATORIES
Model
01H76-01
Catalog number
01H7601
Device description
CELL-DYN Sapphire System RETICULOCYTE REAGENT
Published
2016-09-09
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GJHSTAIN, RETICULOCYTE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GJHStain, ReticulocyteHematology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00380740001124PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00380740001124003807400011243807400011240380740001124

GMDN Terms#

Term, Definition table
TermDefinition
Reticulocyte count IVD, kit, cell countA collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative determination of reticulocyte red blood cells in a clinical specimen using a manual, semi-automated or automated cell count method.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(877)422-2688xx@xx.xx

Regulatory Flags#

DUNS number
079226220
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
00380740153694Alinity01R130201R13022023-10-14
00380740153762Alinity04R461204R46122023-10-14
00380740156305ARCHITECT06K460406K46042020-03-03
00380740156381ARCHITECT06K542206K54222020-03-03
00380740156398ARCHITECT06K552306K55232020-03-03
00380740030056ARCHITECT6K46-0206K46022018-07-31
00380740044831ARCHITECT6K54-2106K54212018-07-31
00380740045593ARCHITECT6K55-2206K55222018-07-31
00380740202798Alinity04W560704W56072025-07-21
00380740203108Alinity04W561504W56152025-07-21
00380740203115Alinity04W562504W56252025-07-21
00380740203139Alinity04W566104W56612025-07-21
00380740192402CELL-DYN09H600309H60032020-12-18
00380740020132CELL-DYN09H46-0209H46022016-06-06
00380740020149CELL-DYN09H47-0209H47022016-06-06
00380740020156CELL-DYN09H48-0209H48022016-06-06
00380740120771CELL-DYN09H610109H61012016-09-09
00380740120788CELL-DYN09H62-0109H62012016-09-09
00380740202668Alinity06P010706P01072025-10-03
00380740202828Alinity06P011506P01152025-10-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00380740213558AlinityABBOTT LABORATORIESGJH2025-09-25
00673693090469EprediaRICHARD-ALLAN SCIENTIFIC COMPANYGJH2024-09-05
00380740137007AlinityAbbott Ireland DiagnosticsGJH2023-11-16
04987562433957UF-Fluorocell SFSYSMEX CORPORATIONGJH2022-11-30
04987562433964UF-Fluorocell CRSYSMEX CORPORATIONGJH2022-11-30
84987562433953UF-Fluorocell SFSYSMEX CORPORATIONGJH2022-11-30
84987562433960UF-Fluorocell CRSYSMEX CORPORATIONGJH2022-11-30
00380740005009CELL-DYNABBOTT LABORATORIESGJH2016-06-06