FDA.reportPublic FDA data

Tasso+ Standard Kit

Primary DI
00850038691172
Brand
Tasso+ Standard Kit
Company
Tasso Inc.
Model
K1042-01
Device description
The product is a blood specimen collection kit that assists in the collection of capillary blood specimens from the upper arm. It is composed of a 510(k) Class II single-use blood lancet (21 CFR 878.4850, FMK) and collection accessories including a bandage, alcohol swab, heat pack, and sample return bag. The kit does not include a specimen collection reservoir; users must obtain a compatible collection tube separately.
Published
2026-07-06
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
PQDBlood Specimen Collection Convenience Kit (Excludes Hiv)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PQDBlood Specimen Collection Convenience Kit (Excludes Hiv)Clinical Chemistry2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850038691172PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850038691172008500386911728500386911720850038691172

GMDN Terms#

Term, Definition table
TermDefinition
Capillary blood collection system IVDAn assembly of devices intended to be used for the collection, preservation, and/or transportation of capillary blood for subsequent analysis and/or other investigation. It is a self-contained unit consisting of micro-needles and a container with a pre-measured amount of vacuum. The device is intended to be placed against the skin where the needles make shallow perforations, from which blood is drawn from the capillaries into the container via the vacuum. It may or may not contain a preservative or anticoagulant (e.g., lithium heparin). This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature00

Sterilization Methods#

Method table
Method
Radiation Sterilization

Contacts#

Phone, Email table
PhoneEmail
1-800-257-2370customerservice@tassoinc.com

Regulatory Flags#

DUNS number
078431936
Device count
1
DM exempt
false
Premarket exempt
true
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
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850038691189Tasso Mini Standard KitK1044-012026-07-06
00850038691158Tasso+K1040-012025-05-13
10850038691155Tasso+K1040-012025-05-13
00850038691011Tasso+ Convenience KitK1019-012022-10-21
00850038691028Tasso+ Convenience KitK1019-022022-10-21
00850038691035Tasso+ Convenience KitK1019-032022-10-21
00850038691042Tasso+ Convenience KitK1019-042022-10-21
00860006434557Tasso+ Convenience KitK1016-042021-12-21
00860006434564Tasso+ Convenience KitK1016-032021-12-21
00860006434571Tasso+ Convenience KitK1016-012021-12-21
00860006434588Tasso+ Convenience KitK1016-022021-12-21
00860006434595Tasso+K1015-012021-12-21
00850038691141Tasso MiniK1037-012025-03-07
10850038691148Tasso MiniK1037-012025-03-07
00850038691004Tasso+K1013-012022-10-21
00850038691134Tasso MiniK1027-012024-08-16
00850038691110Tile-T20PN0583-022025-02-06
10850038691117Tile-T20PN0583-022025-02-06
00860006434540Tasso-M20K1001-022021-07-20
00860006434502Tasso+ Convenience KitK1011-022021-05-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850038691189Tasso Mini Standard KitTasso Inc.PQD2026-07-06
05055273220780BIOHACKER Premium Home Blood Sampling Collection KitRANDOX LABORATORIES LIMITEDPQD2026-05-22
05055273220797MALE HORMONE Premium Home Blood Sampling Collection KitRANDOX LABORATORIES LIMITEDPQD2026-05-22
05055273220803BASELINE Venous Sample Collection kitRANDOX LABORATORIES LIMITEDPQD2026-05-22
05055273220995FEMALE HORMONE Premium Home Blood Sampling Collection KitRANDOX LABORATORIES LIMITEDPQD2026-05-22
05055273221640BASELINE SELF-DRAW Premium Home Blood Sampling Collection KitRANDOX LABORATORIES LIMITEDPQD2026-05-22
00850024881860LetsGetChecked Blood Sample Collection Kit (BIOM2)PRIVAPATH DIAGNOSTICS LIMITEDPQD2026-05-06
00810010895011Aero-MedAERO-MED, LLCPQD2026-05-04
00810010894991Aero-MedAERO-MED, LLCPQD2026-04-07
00810010895004Aero-MedAERO-MED, LLCPQD2026-04-07
10885380211225Aero-MedAERO-MED, LLCPQD2026-03-20
50885380211223Aero-MedAERO-MED, LLCPQD2026-03-20
00850070635158KIT, BLOOD CULTURE COLLECTINGNar Medical Depot, LLCPQD2026-03-19
00810010894885Aero-MedAERO-MED, LLCPQD2026-03-17
50810010894880Aero-MedAERO-MED, LLCPQD2026-03-17
00810010894960Aero-MedAERO-MED, LLCPQD2026-03-17
00850066710272Simple HealthKitSIMPLE HEALTHKIT, INC.PQD2026-01-21
04779054721198RDA SpotRDA SPOT, UABPQD2026-01-15
00850015884351easycareSynchronis Medical, LLCPQD2026-01-07
00850015884368easycareSynchronis Medical, LLCPQD2026-01-07
04779054721129RDA SpotRDA SPOT, UABPQD2025-11-20
04779054721143RDA SpotRDA SPOT, UABPQD2025-11-20
04779054721082BLOODORDA SPOT, UABPQD2025-10-16
04779054721105BLOODORDA SPOT, UABPQD2025-10-16
04779054721112BLOODORDA SPOT, UABPQD2025-10-16
04779054721099BLOODORDA SPOT, UABPQD2025-10-13
04779054720276ZinzinoRDA SPOT, UABPQD2025-10-03
04779054720184ZinzinoRDA SPOT, UABPQD2025-09-16
04779054721013ZinzinoRDA SPOT, UABPQD2025-07-24
00810111410045LetsGetChecked Blood Sample Collection Kit (LIPP2)PRIVAPATH DIAGNOSTICS LIMITEDPQD2025-07-07