FDA.reportPublic FDA data

Caplugs/Evergreen

Primary DI
00810044206203
Brand
Caplugs/Evergreen
Company
CAPlugs
Model
127-1240-010
Catalog number
127-1240-010
Device description
SERUM S CUP 0.5ML FOR ROC/HIT
Published
2022-02-04
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
JCCpH buffer

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JCCPh BufferPathology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810044206203PrimaryGS10
00810044206517Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810044206203008100442062038100442062030810044206203
00810044206517008100442065178100442065170810044206517

GMDN Terms#

Term, Definition table
TermDefinition
Laboratory analyser cuvette IVD, single-useA small volume, rectangular column designed to contain a clinical specimen, reagent, or other material for in vitro diagnostic testing procedures performed by a laboratory analyser. It is transparent to allow light to travel through the contained material and is typically made of plastic, glass or quartz with a flat base and an open top. This is a single-use device.

Contacts#

Phone, Email table
PhoneEmail
+1(716)876-9855christine.koch@caplugs.com

Regulatory Flags#

DUNS number
098203461
Device count
1000
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810044208146Caplugs/Evergreen308-1000-000308-1000-0002024-05-31
00810044208153Caplugs/Evergreen308-1050-FPCSV308-1050-FPCSV2024-05-31
00810044208160Caplugs/Evergreen308-2000-000308-2000-0002024-05-31
00810044208177Caplugs/Evergreen308-4000-000308-4000-0002024-05-31
00810044208351Caplugs/Evergreen127-1758-B20127-1758-B202026-02-06
00810044208368Caplugs/Evergreen127-1758-Y20127-1758-Y202026-02-06
00810044208375Caplugs/Evergreen127-1758-B20127-1758-B202026-02-06
00810044208382Caplugs/Evergreen127-1758-Y20127-1758-Y202026-02-06
00810044206654Caplugs/Evergreen208-3366-050208-3366-0502024-05-31
00810044206661Caplugs/Evergreen208-3367-050208-3367-0502024-05-31
00810044206678Caplugs/Evergreen208-3368-050208-3368-0502024-05-31
00810044206685Caplugs/Evergreen208-3383-03K208-3383-03K2024-05-31
00810044206692Caplugs/Evergreen208-3383-060208-3383-0602024-05-31
00810044206708Caplugs/Evergreen208-3384-060208-3384-0602024-05-31
00810044206715Caplugs/Evergreen208-3385-060208-3385-0602024-05-31
00810044206722Caplugs/Evergreen208-3385-06R208-3385-06R2024-05-31
00810044206739Caplugs/Evergreen208-3385-06S208-3385-06S2024-05-31
00810044206746Caplugs/Evergreen208-3376-050208-3376-0502024-05-31
00810044206753Caplugs/Evergreen208-3377-050208-3377-0502024-05-31
00810044206760Caplugs/Evergreen208-3378-050208-3378-0502024-05-31

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04015630971008Antibody DiluentVentana Medical Systems, Inc.JCC2025-12-15
04015630972432ULTRA Cell Conditioning Solution (ULTRA CC1)Ventana Medical Systems, Inc.JCC2025-12-15
04015630985012ISH Probe DiluentVentana Medical Systems, Inc.JCC2025-12-15
00810170553585IHCSlmp, LLCJCC2025-03-31
00810170553592IHCSlmp, LLCJCC2025-03-31
08435256719499TBS Tween 20 Buffer 10X q.s. 10LVITRO SAJCC2025-02-20
08435804515078TBS Tween 20 Buffer 10XVITRO SAJCC2025-02-20
00348783012699BufferProPREMIER DENTAL PRODUCTS COMPANYJCC2024-12-18
00860011780540Chemical Service Labs, LLCProtean Resources, LLC.JCC2024-03-18
00860011780557Chemical Service Labs, LLCProtean Resources, LLC.JCC2024-03-18
00860011780564Chemical Service Labs, LLCProtean Resources, LLC.JCC2024-03-18
00860011780595Chemical Service Labs, LLCProtean Resources, LLC.JCC2024-03-18
07540207107803EasySep™ BufferStemcell Technologies Canada IncJCC2024-02-08
00380740136994AlinityAbbott Ireland DiagnosticsJCC2023-11-16
00860001977349OnsetOnpharma CompanyJCC2023-06-01
00810047421047N/AScientific Device Laboratory, Inc.JCC2023-01-31
00810047421054N/AScientific Device Laboratory, Inc.JCC2023-01-31
00847627014528PBS Plus 10XBIOCARE MEDICAL LLCJCC2022-12-07
00847627014559Immunocare PBS 10XBIOCARE MEDICAL LLCJCC2022-12-07
00847627014610TBSplus 10XBIOCARE MEDICAL LLCJCC2022-12-07
00847627014627Automation Tween 20, 20XBIOCARE MEDICAL LLCJCC2022-12-07
00847627014634Immunocare TBS Wash Buffer 10XBIOCARE MEDICAL LLCJCC2022-12-07
0084762701466520% Tween 20BIOCARE MEDICAL LLCJCC2022-12-07
0084762701467220% Tween 20BIOCARE MEDICAL LLCJCC2022-12-07
0084762701468920% Tween 20BIOCARE MEDICAL LLCJCC2022-12-07
00847627014641TBS Auto Wash Buffer 20XBIOCARE MEDICAL LLCJCC2022-09-23
00847627014658TBS Auto Wash Buffer 40XBIOCARE MEDICAL LLCJCC2022-09-23
00816085023311Alpha-Tec SystemsAlpha-TEC Systems, Inc.JCC2022-08-10
00816085023328Alpha-Tec SystemsAlpha-TEC Systems, Inc.JCC2022-08-10
00816085020259Alpha-Tec SystemsAlpha-TEC Systems, Inc.JCC2022-08-10