FDA.reportPublic FDA data

US Biotek Laboratories

Primary DI
00860010959244
Brand
US Biotek Laboratories
Company
U.S. Biotek Laboratories LLC
Model
1.0
Catalog number
DBK001
Device description
Single-use convenient dried blood spot collection kit includes dry blood spot card, lancets and return packing for mailing to testing laboratory.
Published
2023-09-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Product Codes#

Code, Name table
CodeName
OIANeonatal Blood Collection Kit And Screening Form (Excludes Hiv Testing)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OIANeonatal Blood Collection Kit And Screening Form (Excludes Hiv Testing)Pathology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860010959244PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860010959244008600109592448600109592440860010959244

GMDN Terms#

Term, Definition table
TermDefinition
Capillary blood collection kit IVDA collection of in vitro diagnostic devices and materials available for use by a patient/layperson outside a clinical setting to collect and mail a capillary blood sample to a clinical laboratory for diagnostic testing or screening purposes. The kit includes a lancet, a blood collection container(s), and a return packing/envelope for mailing to the laboratory. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
094709776
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860010959206US Biotek Laboratories1.0DUK0012023-09-15
00860010959220US Biotek Laboratories1.0UTK0012023-09-15
00860010959268US Biotek Laboratories1.0SCK0012023-09-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10195594816155CARDINAL HEALTHCardinal Health 200, LLCOIA2022-10-12
50195594816153CARDINAL HEALTHCardinal Health 200, LLCOIA2022-10-12
10195594508685CARDINAL HEALTHCardinal Health 200, LLCOIA2022-05-13
50195594508683CARDINAL HEALTHCardinal Health 200, LLCOIA2022-05-13
10195594480271CARDINAL HEALTHCardinal Health 200, LLCOIA2021-12-16
50195594480279CARDINAL HEALTHCardinal Health 200, LLCOIA2021-12-16
10195594325312CARDINAL HEALTHCardinal Health 200, LLCOIA2021-09-29
50195594325310CARDINAL HEALTHCardinal Health 200, LLCOIA2021-09-29
10888439229752CARDINAL HEALTHCardinal Health 200, LLCOIA2018-11-13
50888439229750CARDINAL HEALTHCardinal Health 200, LLCOIA2018-11-13