FIRST SIGN® - DOA 15 in 1 Test Controls Set, 1 Positive & 1 - HEMOSURE INC.

Duns Number:806777541

Device Description: DOA 15 in 1 Test Controls Set, 1 Positive & 1 Negative Control (20mL each); First Sign for DOA 15 in 1 Test Controls Set, 1 Positive & 1 Negative Control (20mL each); First Sign for HemosureAMP/BARB/BUP/BZO/COC/EDDP/mAMP/MDMA/MOR/MTD/OPI/OXY/PCP/TCA/THC

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More Product Details

Catalog Number

D0115TC-02

Brand Name

FIRST SIGN®

Version/Model Number

D0115TC-02

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

December 31, 2018

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

DIF

Product Code Name

Drug Mixture Control Materials

Device Record Status

Public Device Record Key

99e84341-390d-456a-ad7f-fe135d814514

Public Version Date

December 31, 2018

Public Version Number

3

DI Record Publish Date

September 21, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"HEMOSURE INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 4
2 A medical device with a moderate to high risk that requires special controls. 7