FDA.reportPublic FDA data

ARCHITECT

Primary DI
00380740014209
Brand
ARCHITECT
Company
ABBOTT IRELAND
Model
7K62-01
Catalog number
07K6201
Device description
ARCHITECT TSH Calibrators
Published
2016-09-09
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
JJXSINGLE (SPECIFIED) ANALYTE CONTROLS (ASSAYED AND UNASSAYED)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JJXSingle (Specified) Analyte Controls (Assayed And Unassayed)Clinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00380740014209PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00380740014209003807400142093807400142090380740014209

GMDN Terms#

Term, Definition table
TermDefinition
Thyroid stimulating hormone (TSH) IVD, calibratorA material which is used to establish known points of reference for an assay intended to be used for the quantitative measurement of thyroid stimulating hormone (TSH) in a clinical specimen.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Humidity0 Percent (%) Relative Humidity0 Percent (%) Relative Humidity
Handling Environment Temperature2 Degrees Celsius8 Degrees Celsius
Storage Environment Humidity0 Percent (%) Relative Humidity0 Percent (%) Relative Humidity
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
989964119
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00380740155322Alinity04T992004T99202025-12-19
00380740155339Alinity04T993004T99302025-12-19
00380740155612Alinity04T852004T85202025-12-19
00380740156718ARCHITECT04S892004S89202025-12-19
00380740195236ARCHITECT04T032004T03202025-12-19
00380740195243ARCHITECT04T033004T03302025-12-19
00380740106003ARCHITECT7K78-3507K78352025-12-12
00380740158125Alinity04T883004T88302025-04-15
00380740158132ARCHITECT04S922004S92202025-04-15
00380740158149ARCHITECT04S923004S92302025-04-15
00380740170004ARCHITECT08G662408G66242024-09-13
00380740155285Alinity04T822004T82202024-08-15
00380740155292Alinity04T823004T82302024-08-15
00380740155346Alinity04U302004U30202024-08-15
00380740155353Alinity04U303004U30302024-08-15
00380740155483ARCHITECT04U452004U45202024-08-15
00380740155490ARCHITECT04U453004U45302024-08-15
00380740155872ARCHITECT04T342004T34202024-08-15
00380740155889ARCHITECT04T343004T34302024-08-15
00380740159528Alinity04T912004T91202024-08-15

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Primary DI, Brand, Company table
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00630414608778Atellica IM aTPOII MCMSiemens Healthcare Diagnostics Inc.JJX2026-01-26
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MHC1101665152EasyTouchMHC MEDICAL PRODUCTS, LLCJJX2026-01-07
00850011135846VALIDATELgc Clinical Diagnostics, Inc.JJX2026-01-06
04560189283923Hemoglobin A1c Control SetTOSOH CORPORATIONJJX2026-01-05
00380740189839AlinityAbbott GmbHJJX2026-01-01
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10758750032891VITROSORTHO CLINICAL DIAGNOSTICSJJX2025-12-30
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00630414608822ADVIA Centaur aTPOII MCMSiemens Healthcare Diagnostics Inc.JJX2025-11-21
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