FDA.reportPublic FDA data

ARCHITECT

Primary DI
00380740019655
Brand
ARCHITECT
Company
ABBOTT LABORATORIES
Model
9D87-21
Catalog number
09D8721
Device description
Acid Phosphatase
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
CKBAcid phosphatase, naphthyl phosphate

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CKBAcid Phosphatase, Naphthyl PhosphateClinical Chemistry2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00380740019655PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00380740019655003807400196553807400196550380740019655

GMDN Terms#

Term, Definition table
TermDefinition
Total acid phosphatase (TAP) IVD, reagentA substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of total acid phosphatase (TAP) in a clinical specimen.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature029 Degrees Celsius
Special Storage Condition, Specify00If reconstituted, protect from light.
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
Kit
true
Lot or batch
true
Expiration date on label
true
Contains natural rubber latex
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
10673486001198ACID PHOSPHATASE REAGENT SET (KINETIC METHOD)TECO DIAGNOSTICSCKB2023-07-20
00817302024241CAROLINA LIQUID CHEMISTRIES CORP.® GGT REAGENT KIT CC209CAROLINA LIQUID CHEMISTRIES CORPORATIONCKB2022-08-19
00817302024050CLC GAMMA-GLUTAMYL TRANSFERASE GGT REAGENT KIT AU-209CAROLINA LIQUID CHEMISTRIES CORPORATIONCKB2022-07-06
05055273208122ACID PHOSPHATASE (ACP)RANDOX LABORATORIES LIMITEDCKB2019-05-31
05055273200065ACPRANDOX LABORATORIES LIMITEDCKB2016-09-09